Class II · Moderate risk
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets
CGMP Deviations
FDA Drug Recalls
982 recalls · Class II, newest first
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Docetaxel injection concentrate
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Class II · Moderate risk
Macroaggregated albumin
Lack of Assurance of Sterility
Class II · Moderate risk
Loxapine Capsules
CGMP Deviations
Class II · Moderate risk
Loxapine Capsules
CGMP Deviations
Class II · Moderate risk
Amlodipine and Benazapril HCL Capsules
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Class II · Moderate risk
Amlodipine and Benazapril HCL Capsules
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Class II · Moderate risk
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class II · Moderate risk
Clindamycin 300 mg capsules
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class II · Moderate risk
Chlorhexidine 0.12% liquid
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class II · Moderate risk
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class II · Moderate risk
Clindamycin 150 mg capsules
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class II · Moderate risk
Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Class II · Moderate risk
Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Class II · Moderate risk
Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Class II · Moderate risk
Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Class II · Moderate risk
Alprostadil 20 mcg/mL
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Class II · Moderate risk
Methylcobalamin for injection
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.
Class II · Moderate risk
Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets USP
Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
Class II · Moderate risk
Fluocinolone Acetonide Topical Oil
Subpotent Drug
Class II · Moderate risk
Fluocinolone Acetonide Topical Oil
Subpotent Drug