Class I · High risk Terminated
Piperacillin and Tazobactam for Injection
Reason Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
FDA Drug Recalls
17,898 recalls, newest first
Class I · High risk Terminated
Ampicillin and Sulbactam for Injection
Reason Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
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
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 III · Low risk Terminated
Lidocaine Patch 5%
Reason Failed Stability Specifications
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 III · Low risk Terminated
Riomet
Reason Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
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.