Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-release Tablets USP
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Irinotecan HCL Injection
Reason Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Class II · Moderate risk Terminated
Irinotecan HCL Injection
Reason Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Class III · Low risk Terminated
Nabumetone Tablets
Reason Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
Class II · Moderate risk Terminated
Aripiprazole Tablets
Reason Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Class II · Moderate risk Terminated
Nystatin Cream
Reason Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Class II · Moderate risk Terminated
Nystatin Cream
Reason Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Class I · High risk Terminated
Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule
Reason Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.
Class II · Moderate risk Terminated
Time-Cap Labs
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class III · Low risk Terminated
Prednisolone Sodium Phosphate Oral Solution
Reason Discoloration: Out of Specification (OOS) result for APHA Color Test.
Class II · Moderate risk Terminated
metFORMIN HCL ER 500 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
metFORMIN HCL ER USP 500 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class III · Low risk Terminated
Brimonidine Tartrate Opthalmic Solution 0.2%
Reason Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Class III · Low risk Terminated
Brimonidine Tartrate Opthalmic Solution 0.2%
Reason Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Class III · Low risk Terminated
Brimonidine Tartrate Opthalmic Solution 0.2%
Reason Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm
Reason Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Class II · Moderate risk Terminated
Walker Hand Sanitizer
Reason Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Class II · Moderate risk Terminated
Walker Emulsions Hand Sanitizer
Reason Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Class II · Moderate risk Terminated
Soft Whisper by Powerstick Dandruff Shampoo
Reason cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended - Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Handese Advanced Instant Hand Sanitizer
Reason Subpotent Drug: Product was found to be subpotent. Product also has high pH levels
Class II · Moderate risk Ongoing
amneal Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level