Class II · Moderate risk
Heparin Sodium 5
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
FDA Drug Recalls
708 recalls · Class II, newest first
Class II · Moderate risk
Tropical Lip Moisturizer
Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
Class II · Moderate risk
Clozapine Tablets USP tablet
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Class II · Moderate risk
Koala Hand Sanitizer
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class II · Moderate risk
Koala Hand Sanitizer
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class II · Moderate risk
Koala Hand Sanitizer
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class II · Moderate risk
Metformin Hydrochloride Extended-release Tablets USP
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Irinotecan HCL Injection
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Class II · Moderate risk
Irinotecan HCL Injection
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Class II · Moderate risk
Aripiprazole Tablets
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Class II · Moderate risk
Nystatin Cream
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Class II · Moderate risk
Nystatin Cream
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Class II · Moderate risk
Time-Cap Labs
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
metFORMIN HCL ER 500 mg
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
metFORMIN HCL ER USP 500 mg
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm
Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Class II · Moderate risk
Walker Hand Sanitizer
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
Walker Emulsions Hand Sanitizer
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
Soft Whisper by Powerstick Dandruff Shampoo
cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Metformin Hydrochloride Extended - Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Handese Advanced Instant Hand Sanitizer
Subpotent Drug: Product was found to be subpotent. Product also has high pH levels