Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Homatropine Methlybromide Oral…
Reason Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Cefdinir for Oral Suspension USP
Reason Presence of Foreign substance: identified as a dead ant.
Class III · Low risk Terminated
Cefdinir for Oral Suspension USP
Reason Presence of Foreign substance: identified as a dead ant.
Class III · Low risk Terminated
Cephalexin for Oral Suspension USP
Reason Presence of Foreign substance: identified as a dead ant.
Class II · Moderate risk Terminated
LETS GEL KIT Convenience Pack
Reason Microbial contamination of non-sterile product.
Class II · Moderate risk Terminated
Potassium Phosphate
Reason Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Class II · Moderate risk Terminated
Lannett Ranitidine Syrup
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class I · High risk Terminated
0.9% Sodium Chloride Injection
Reason Presence of Particulate Matter.
Class I · High risk Terminated
LACTATED RINGER'S Injection
Reason Presence of Particulate Matter.
Class II · Moderate risk Terminated
Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.