Class I - Dangerous
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class I - Dangerous
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.
Park Avenue Compounding
Class I - Dangerous
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Class I - Dangerous
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class I - Dangerous
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06
Zydus Pharmaceuticals (USA)
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by McKesson Medical-Surgical Inc., Richmond, VA 23233.
DermaRite Industries
Class I - Dangerous
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class I - Dangerous
Subpotent Drug
4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04
DermaRite Industries
Class I - Dangerous
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30
Alembic Pharmaceuticals Limited
Class I - Dangerous
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class I - Dangerous
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class I - Dangerous
Subpotent drug; Clavulanate Potassium component
Class I - Dangerous
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Class I - Dangerous
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class I - Dangerous
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class I - Dangerous
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01
FARMAKEIO OUTSOURCING
Class I - Dangerous
CGMP Deviations: Potential presence of metal particulate matter