Class II · Moderate risk Terminated
Loxapine Capsules
Reason GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Loxapine Capsules
Reason GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Class II · Moderate risk Terminated
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg
Reason CGMP Deviations
Class II · Moderate risk Terminated
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg
Reason CGMP Deviations
Class II · Moderate risk Terminated
Docetaxel injection concentrate
Reason Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Class II · Moderate risk Terminated
Macroaggregated albumin
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Loxapine Capsules
Reason CGMP Deviations
Class II · Moderate risk Terminated
Loxapine Capsules
Reason CGMP Deviations
Class II · Moderate risk Terminated
Amlodipine and Benazapril HCL Capsules
Reason cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Class II · Moderate risk Terminated
Amlodipine and Benazapril HCL Capsules
Reason cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Class II · Moderate risk Terminated
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets
Reason 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 Terminated
Clindamycin 300 mg capsules
Reason 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 Terminated
Chlorhexidine 0.12% liquid
Reason 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 Terminated
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets
Reason 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 Terminated
Clindamycin 150 mg capsules
Reason 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 Terminated
Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL
Reason 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 Terminated
Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL
Reason 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 Terminated
Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml
Reason 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 Terminated
Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml
Reason 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 Terminated
Alprostadil 20 mcg/mL
Reason 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 Terminated
Methylcobalamin for injection
Reason 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 Terminated
Metoprolol Succinate Extended-Release Tablets
Reason 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 Terminated
Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg
Reason 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 Terminated
Sulfamethoxazole and Trimethoprim Tablets USP
Reason 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.