Class I - Dangerous
Failed Dissolution Specifications
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboard drums. Net weight 40 kg
Cambrex Charles City
Class I - Dangerous
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
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
Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
Teva Pharmaceuticals USA
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Class I - Dangerous
Subpotent Drug: Out of specification result for pramoxine hydrochloride
Class I - Dangerous
Subpotent Drug: out of specification results for assay test.
HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459
Town and Country Compounding and Consultation Services
Class I - Dangerous
Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).
Class I - Dangerous
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.