Drug and pharmaceutical recalls
17625 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-06-21FDA-DrugMylan Pharmaceuticals Inc.Class IIIMontelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
- 2017-06-21FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327
cGMP Deviations; lack of quality assurance.
- 2017-06-21FDA-DrugComplete Pharmacy and Medical Solutions LLCClass IHuman Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
- 2017-06-21FDA-DrugComplete Pharmacy and Medical Solutions LLCClass IHuman Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIVANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, NDC# 61553-027-34, 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
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIVANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237, NDC# 61553-037-34, 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
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIVANCOMYCIN 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
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIIPotassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIIPotassium 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
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIIPotassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIIPotassium 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
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIIPotassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIPotassium 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
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIIPotassium 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
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIIPotassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugSafecor Health, LLCClass IIMetronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402
CGMP Deviations
- 2017-06-21FDA-DrugSafecor Health, LLCClass IIDoxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 0143314205
CGMP Deviations
- 2017-06-21FDA-DrugSafecor Health, LLCClass IIAcyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801, NDC 0093894305
CGMP Deviations
- 2017-06-21FDA-DrugSafecor Health, LLCClass IICalcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904323392.
CGMP Deviations
- 2017-06-21FDA-DrugSafecor Health, LLCClass IIAtorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009
CGMP Deviations
- 2017-06-21FDA-DrugSafecor Health, LLCClass IIAcetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280.
CGMP Deviations
- 2017-06-21FDA-DrugBausch & Lomb, Inc.Class IINasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pump bottle, Distributed by: Medtech Products, Inc., Tarrytown, NY 10591, UPC 8 148332 01101 7.
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
- 2017-06-21FDA-DrugHospira Inc., A Pfizer CompanyClass IILevophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
- 2017-06-14FDA-DrugHetero USA IncClass IIIAcyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, by Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-778-01
Presence of Foreign Substance: human hair melded into tablet.
- 2017-06-14FDA-DrugQualgenClass IIEstradiol 6 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: 69761-006-01.
CGMP deviations- Lack of Quality Assurance
- 2017-06-14FDA-DrugQualgenClass IIEstradiol 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
CGMP deviations- Lack of Quality Assurance
- 2017-06-14FDA-DrugQualgenClass IIEstradiol 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
CGMP deviations- Lack of Quality Assurance
- 2017-06-14FDA-DrugQualgenClass IIEstradiol 15 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: 69761-015-01
CGMP deviations- Lack of Quality Assurance
- 2017-06-14FDA-DrugQualgenClass IIEstradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.
CGMP deviations- Lack of Quality Assurance
- 2017-06-14FDA-DrugQualgenClass IIEstradiol 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
CGMP deviations- Lack of Quality Assurance
Get notified about new drug recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief