Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90
Hetero Drugs Ltd. - Unit 1
Class I - Dangerous
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Dissolution Specifications; 18 month stability time point
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
Fresenius Kabi USA
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class I - Dangerous
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class I - Dangerous
Failed Dissolution Specifications; 18 month stability time point
Class I - Dangerous
Failed Dissolution Specifications; 18 month stability time point
Class I - Dangerous
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class I - Dangerous
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Class I - Dangerous
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73
Teva Pharmaceuticals USA
Class I - Dangerous
Subpotency: due to a low, out of specification test result for assay during stability testing.
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
Vintage Pharmaceuticals LLC
Class I - Dangerous
Failed Impurities/ Degradation Specifications
Class I - Dangerous
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
Roxane Laboratories
Class I - Dangerous
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Class I - Dangerous
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules