💊

Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141

Pharmedium Services

Class I - Dangerous

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Feb 17, 2017 Prescription Drugs Nationwide View Details →

Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Pharmedium Services

Class I - Dangerous

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Feb 17, 2017 Prescription Drugs Nationwide View Details →

Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Pharmedium Services

Class I - Dangerous

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Feb 17, 2017 Prescription Drugs Nationwide View Details →

Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93

Mylan Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities

May 9, 2017 Prescription Drugs Nationwide View Details →

VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Pharmedium Services

Class I - Dangerous

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Feb 17, 2017 Prescription Drugs Nationwide View Details →

Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Pharmedium Services

Class I - Dangerous

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Feb 17, 2017 Prescription Drugs Nationwide View Details →

Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009

Safecor Health

Class I - Dangerous

CGMP Deviations

Jul 7, 2016 Prescription Drugs View Details →

Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 0143314205

Safecor Health

Class I - Dangerous

CGMP Deviations

Jul 7, 2016 Prescription Drugs View Details →

Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801, NDC 0093894305

Safecor Health

Class I - Dangerous

CGMP Deviations

Jul 7, 2016 Prescription Drugs View Details →

Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402

Safecor Health

Class I - Dangerous

CGMP Deviations

Jul 7, 2016 Prescription Drugs View Details →

Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01

Qualgen

Class I - Dangerous

CGMP deviations- Lack of Quality Assurance

Apr 19, 2017 Prescription Drugs Nationwide View Details →

Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-012-01

Qualgen

Class I - Dangerous

CGMP deviations- Lack of Quality Assurance

Apr 19, 2017 Prescription Drugs Nationwide View Details →

Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81

Dr. Reddy's Laboratories

Class I - Dangerous

Failed Dissolution Specifications: out of specification results observed for low dissolution.

May 22, 2017 Prescription Drugs Nationwide View Details →

Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For Subcutaneous Use Only Rx Only Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-010-01

Qualgen

Class I - Dangerous

CGMP deviations- Lack of Quality Assurance

Apr 19, 2017 Prescription Drugs Nationwide View Details →

Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code E1435.

Spectrum Laboratory Products

Class I - Dangerous

CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.

Apr 13, 2017 Prescription Drugs Nationwide View Details →