Class I - Dangerous
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
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Prescription Drugs
💊 Drugs • 11,927 recalls
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.
HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-20
Pharm D Solutions
Class I - Dangerous
Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct
Class I - Dangerous
Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.
Class I - Dangerous
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04
Pharm D Solutions
Class I - Dangerous
Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct
Class I - Dangerous
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Class I - Dangerous
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Class I - Dangerous
CGMP Deviations
Carnitine-L 250 mg/mL Injectable, 30 mL vials, Rx only, Compounded by Wells Pharmacy, Ocala, FL
Wells Pharmacy Network
Class I - Dangerous
Lack of Assurance of Sterility