CLOPIDOGREL 75 MG

On 01/04/2018, International Laboratories LLC recalled Lot Number 117099A of CLOPIDOGREL 75 MG. (NDC# 54458-0888-16) due to a labeling mix-up. Simvastatin tablets found in bottles labeled as Clopidogrel tablets. The U.S. Food and Drug Administration (FDA) has issued a Recall Class 1 of the affected medications. 

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm

The detailed information of the recalled product is listed below:

Recalled Drug: CLOPIDOGREL 75 MG
NDC Number: 54458-0888-16
Lot Numbers: 117099A
Expiration Date: Exp. 08/19

What you should do:

  • Do not continue to use CLOPIDOGREL 75 MG if it has been recalled
  • Check your prescription label to see if you have CLOPIDOGREL 75 MG of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178. 

PRAVASTATIN SODIUM 10 & 20 MG

On 01/12/2018, International Laboratories LLC., recalled Lot Numbers 1117093A and 117103A of PRAVASTATIN SODIUM 10 & 20 MG tablets (NDC# 54458-0927-16 and 54458-0926-16) due to a tablet mix-up. Bottles of medication could contain Pravastatin 10 mg and 20 mg tablets in the same bottle. The U.S. Food and Drug Administration (FDA) has issued a Recall Class #2 of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: Pravastatin 10 and 20mg

NDC Number: 54458-0927-16 and 54458-0926-16

Lot Numbers: 1117093A and 117103A

Expiration Date: Exp. 06/19 and Exp. 03/19

What you should do:

  • Do not continue to use PRAVASTATIN SODIUM if it has been recalled
  • Check your prescription label to see if you have PRAVASTATIN SODIUM of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Divalproex Sodium DR 500 MG

On 01/17/2018, Unichem Pharmaceuticals USA Inc. recalled Lot Number ZDPH17040 of Divalproex Sodium DR 500 MG (NDC# 29300-0140-01) due to presence of an anti-fungal agent (metronidazole powder) found in one bottle. The U.S. Food and Drug Administration (FDA) has issued a Class II of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: Divalproex Sodium DR 500 MG
NDC Number: 29300-0140-01
Lot Numbers: ZDPH17040
Expiration Date: N/A

What you should do:

  • Do not continue to use Divalproex Sodium DR 500 MG if it has been recalled.
  • Check your prescription label to see if you have Divalproex Sodium DR 500 MG of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178. 

 

Diphenoxylate and Atropine 2.5 mg/0.025mg


On January 4, 2018, Pfizer Inc. recalled Diphenoxylate and Atropine 2.5 mg/0.025mg (NDC# 59762-1061-01 and 59762-1061-02) due to weight variations resulting in tablets that are the incorrect strength. The U.S. Food and Drug Administration (FDA) has issued a Recall Class #1 of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: Diphenoxylate and Atropine 2.5 mg/0.025mg
  • NDC Number: 59762-1061-01 and 59762-1061-02
  • Lot Number: R83962, R93347, R93348, R93349, R93350, R93351, R93352, R93356,
  • R93357, R93358, R97310, S57831, S57832, S57834
  • Expiration Date: 2021 OCT 31, 2021 NOV 30

What you should do:
Do not continue to use Diphenoxylate and Atropine 2.5 mg/0.025mg if it has been recalled. 

Check your prescription label to see if you have Diphenoxylate and Atropine 2.5 mg/0.025mg of the affected lot numbers and expiration dates.

If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Pravastatin 40 MG

On 12/01/2017, International Laboratories, Inc. recalled Lot # 115698A of Pravastatin 40 MG NDC# 54458-925-16 due to a labeling mix-up. Product labeled as Pravastatin Sodium tablets 40 mg was filled with Bupropion Hydrochloride XL tablets 300 mg. The U.S. Food and Drug Administration (FDA) has issued a Recall Class # I of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: PRAVASTATIN SODIUM 40 MG
  • NDC Number: 54458-925-16
  • Lot Number: Lot # 115698A
  • Expiration Date: 02/2019

What you should do:

Do not continue to use Pravastatin 40 MG  if it has been recalled

Check your prescription label to see if you have Pravastatin 40 MG of the affected lot numbers and expiration dates.

If you have the medication, contact the pharmacy that you received it from.

Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.\

 

Paroxetine 30 MG

On 11/20/2017, Cadila Healthcare Ltd. recalled lot numbers Z701308, Z701309, and Z701310 of PAROXETINE 30 MG (NDC# 68382-099-06, 68382-099-05, and 68382-099-10) due to presence of foreign tablets. Risperidone tablets were found in bottles of Paroxetine tablets. The U.S. Food and Drug Administration (FDA) had issued a Recall Class II of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: PAROXETINE HCL 30 MG
  • NDC Number: 68382-099-06, 68382-099-05, and 68382-099-10
  • Lot Number: Z701308, Z701309, and Z701310
  • Expiration Date: April 2019

What you should do:

Do not continue to use PAROXETINE HCL 30 MG if it has been recalled

Check your prescription label to see if you have PAROXETINE HCL 30 MG of the affected lot numbers and expiration dates.

If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

 

ELIQUIS 5mg Tablets

On 06/10/2017 Bristol-Myers Squibb recalled Lot Number HN0063 of ELIQUIS 5mg tablets NDC# 00003-0894-21 due to a tablet mix-up. A bottle labeled as Eliquis 5mg was found to contain Eliquis 2.5mg tablets. The U.S. Food and Drug Administration (FDA) has issued a Recall Class I of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: ELIQUIS 5mg Tablets
NDC Number: 00003-0894-21
Lot Numbers: HN0063
Expiration Date: September 2019

What you should do:

Do not continue to use ELIQUIS 5mg if it has been recalled.

Check your prescription label to see if you have ELIQUIS of the affected lot numbers and expiration dates.

If you have the medication, contact the pharmacy that you received it from.

Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

 

SAPHRIS 10mg

On 05/31/2017, Forest Laboratories, LLC recalled Lot Numbers W00733 and W00946 of SAPHRIS 10mg NDC# 00456241060 due to a labeling mix-up. Blister lidding foil and shell-packs labeled as 10 mg actually contained5 mg tablets. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: SAPHRIS 10mg
  • NDC Number: 00456241060
  • Lot Numbers: W00733 and W00946
  • Expiration Date: Apr 2019

What you should do:

Do not continue to use SAPHRIS 10mg if it has been recalled

Check your prescription label to see if you have SAPHRIS of the affected lot numbers and expiration dates.

If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

 

Mibelas™ 24 Fe (Norethindrone Acetate and EthinylEstradiol 1mg/0.02mg Chewable Tablets and Ferrous Fumarate 75 mg) Tablets

On 05/25/2017, Lupin Pharmaceuticals Inc. recalled Lot Number L600518 of Mibelas™ 24 Fe NDC # 68180-0911-13. The U.S. Food and Drug Administration (FDA) has issued a Recall Class I of the affected medications due to a packaging error that left tablets out of sequence. The blister pack was rotated out of orientation so that the first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: Mibelas™ 24 Fe
NDC Number: 68180-0911-13
Lot Numbers: L600518
Expiration Date: 05/31/2018

What you should do:

Do not continue to use Mibelas™ 24 Fe if it has been recalled

Check your prescription label to see if you have Mibelas™ 24 Fe of the affected lot numbers and expiration dates.

If you have the medication, contact the pharmacy that you received it from.

Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178. 

 

LORAZEPAM 0.5 MG

On 9/28/2017, Leading Pharma recalled Lot #E00717 of LORAZEPAM 0.5 MG (NDC# 69315090405) due to a labeling error. Bottle labeled as 0.5 mg tablets contained 1 mg tablets. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LORAZEPAM 0.5 MG
NDC Number: 69315090405
Lot Numbers: Lot #E00717

What you should do:

Do not continue to use LORAZEPAM 0.5 MG if it has been recalled.

Check your prescription label to see if you have LORAZEPAM 0.5 MG of the affected lot numbers and expiration dates.

If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

RIOMET 500 MG/5ML

On 4/18/2017, Sun Pharmaceutical Industries, Inc. recalled Lot A160031A and Lot: A160031B of RIOMET 500 MG/5ML (NDC# 10631-206-01 and 10631-206-02) due to a risk of product contamination with Scopulariopsis brevicaulis, and the potential for infection. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: RIOMET 500 MG/5ML
NDC Number: 10631-206-01 and 10631-206-02
Lot Numbers: A160031A and A160031B
Expiration Date: 01/2018

What you should do:

Do not continue to use RIOMET 500 MG/5ML if it has been recalled.

Check your prescription label to see if you have RIOMET 500 MG/5ML of the affected lot numbers and expiration dates.

If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

DAYTRANA

On 8/30/2017, Noven Pharmaceuticals recalled lot numbers 80426, 80442, 80439, 80438, 80431 and 80433 of Daytrana 10mg, 15mg, 20mg and 30mg (NDC# 68968-5552-3, 68968-5553-3, 68968-5554-3 and 68968-5555-3) patches due to defective delivery of medication. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm

The detailed information of the recalled product is listed below:

Recalled Drug: DAYTRANA 10mg
NDC Number: 68968555203
Lot Numbers: 80433
Expiration Date: 8/2017

Recalled Drug: DAYTRANA 15mg
NDC Number: 68968555303
Lot Numbers: 80426    
Expiration Date: 10/2017

Recalled Drug: DAYTRANA 20mg
NDC Number: 68968555403
Lot Numbers: 80431
Expiration Date: 8/2017

Recalled Drug: DAYTRANA 30mg
NDC Number: 68968555503
Lot Numbers: 80442, 80439, and 80438
Expiration Date: 8/2017 and 10/2017

What you should do:

  • Do not continue to use DAYTRANA if it has been recalled
  • Check your prescription label to see if you have DAYTRANA of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Paroxetine

On August 18, 2017, Zydus Pharmaceuticals recalled Lot #: Z701133 of Paroxetine HCL (NDC#68382-099-06) due to the presence of risperidone tablets in bottles of paroxetine. The U.S. Food and Drug Administration (FDA) has issued a Recall Class #2 of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. 

The detailed information of the recalled product is listed below:

Recalled Drug: Paroxetine HCL

NDC Number: NDC 68382-099-06

Lot Numbers: Z701133

Expiration Date: 03/19

What you should do:

  • Do not continue to use Paroxetine HCL if it has been recalled.
  • Check your prescription label to see if you have Paroxetine HCL of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to the FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178

All Liquid Products Manufactured by Pharmatech LLC and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories 

On 08/10/2017 PharmaTech LLC recalled the products listed below due to possible contamination. The U.S. Food and Drug Administration (FDA) has issued a recall Class I of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

LEADER BRAND

Recalled Drug: Liquid Multivitamin Supplement for Infants and Toddlers 50 mL

                           Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 Ml

NDC/UPC Number: 096295128611, 096295128628

Lot Numbers: All Lot Numbers

Expiration Date: All Expiration Dates

MAJOR PHARMACEUTICALS

Recalled Drug:  Certa-Vite Liquid 236ML, Poly-Vita Drops 50ML , Poly-Vita Drops W/Iron 50ML , Ferrous Drops Iron Supp 50ML , D-Vita Drops 50ML , Tri-Vita Drops 50ML, Senna Syrup 237ML
NDC Number: 00904-5023-09, 00904-5099-50, 00904-5100-50, 00904-5100-50, 00904-6060-50, 00904-6273-50, 00904-6274-50, 00904-6289-09
Lot Numbers: All Lot Numbers
Expiration Date: All Expiration Dates 

RUGBY LABORATORIES

Recalled Drug:  C Liquid 500mg 118ML , Diocto Liquid 50mg/5ml 473ML , Ferrous Sulfate Elixir 473ML, Fer Iron Liquid 50ML 50ML , Senexon Liquid 237ML , Diocto Syrup 60MG/15ML 473ML , Aller Chlor Syrup   120ML, Calcionate Syrup ,Cerovite Liquid 236ML, D3 400iu Liquid 50ML , Poly-Vitamin Liquid 50ML , Tri-Vitamin Liquid 50ML , Poly-Vitamin W/Iron Liquid 50ML

NDC Number: 00536-0160-97 00536-2770-85, 00536-2790-59 , 00536-8400-80, 00536-8450-80, 00536-8501-80, 00536-8530-80, 00536-0590-85, 00536-0650-85, 00536-0710-80, 00536-1000-59, 00536-1001-85, 00536-1025-47

Lot Numbers: All Lot Numbers

Expiration Dates: All Expiration Dates

What you should do:

  • Do not continue to use any of the above medications listed if it has been recalled
  • Check your prescription label to see if you have any of the indicated medication listed above of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178. 

Diocto Liquid and Diocto Syrup

On August 2, 2017, PharmaTech, LLC recalled all lot numbers of Diocto Liquid and Diocto Syrup (NDC# 0536-0590-85 & 0536-1001-85 ) due to a risk of product contamination with Burkholderia cepacia, and the potential for infection.

The U.S. Food and Drug Administration (FDA) has issued a Recall Class 1 of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: Diocto Liquid and Diocto Syrup
NDC Number: NDC 0536-0590-85 & 0536-1001-85
Lot Numbers: All
Expiration Date: All

What you should do:

  • Do not continue to use Diocto Liquid and Diocto Syrup if it has been recalled
  • Check your prescription label to see if you have Diocto Liquid and Diocto Syrup of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

DIVALPROEX SODIUM

On August 9, 2017 Cadila Healthcare Ltd, recalled (see FDA URL below) of DIVALPROEX SODIUM (NDC#68382-031-01, 68382-032-01, 68382-032-05, 68382-033-01, 68382-033-05) Due to failure to dissolve appropriately, affecting the dose a patient may receive.

The U.S. Food and Drug Administration (FDA) has issued a Class II of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: DIVALPROEX SODIUM 125mg, 250mg, and 500mg
NDC Number: 68382-031-01, 68382-032-01, 68382-032-05, 68382-033-01, 68382-033-05
Lot Number: To verify affected lot numbers and expiration dates please refer to FDA website at: https://www.accessdata.fda.gov/scripts/ires/index.cfm
Expiration Date: To verify affected lot numbers  and expiration dates please refer to FDA website at: https://www.accessdata.fda.gov/scripts/ires/index.cfm

What you should do:

  • Do not continue to use DIVALPROEX SODIUM if it has been recalled
  • Check your prescription label to see if you have DIVALPROEX SODIUM of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto- Injectors

On 03/31/2017, Mylan recalled lot numbers (5GN767, 5GN773, 5GM631, 5GM640, 6GN215, 6GM082, 6GM072, 6GM081, 6GM088, 6GM199, 6GM091, 6GM198, 6GM087) of EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors (NDC# 49502-501-02, 49502-500-02) for failure to activate the device due to a potential defect.

The U.S. Food and Drug Administration (FDA) has issued a Class I of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled products is listed below:

Recalled Drug: EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors
NDC Number: 49502-501-02, 49502-500-02
Lot Numbers: 5GN767, 5GN773, 5GM631, 5GM640, 6GN215, 6GM082, 6GM072, 6GM081, 6GM088, 6GM199, 6GM091, 6GM198, 6GM087
Expiration Date: Apr-17, May-17, Sep-17, Oct-17

What you should do:

  • Do not continue to use EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors if it  has been recalled
  • Check your prescription label to see if you have EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL

On 01/18/2017, VistaPharm recalled (Lot Numbers: 427900, 426700, 424800, 423600, 420800, 416300, 407700, 407300, 405900, 403900, 426900, 404700, 390200) of Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (NDC# 66689-401-50, 66689-403-16), the purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

The U.S. Food and Drug Administration (FDA) has issued a Class II of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below:

Recalled Drug: Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL
NDC Number: 66689-401-50, 66689-403-16
Lot Numbers: 427900, 426700, 424800, 423600, 420800, 416300, 407700, 407300, 405900, 403900, 426900, 404700, 390200
Expiration Date: 11/17, 10/17, 09/17, 08/17, 06/17, 05/17, 02/17

What you should do:

  • Do not continue to use Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL if it has been recalled
  • Check your prescription label to see if you have Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.