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.
FDA Drug Recalls
11,815 recalls · Class II, 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
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 II · Moderate risk Terminated
Time-Cap Labs
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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 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 Terminated
Unasyn
Reason Presence of Particulate Matter: particulate matter identified after reconstitution.
Class II · Moderate risk Terminated
Gaviscon Liquid Antacid Extra Strength
Reason Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk Terminated
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry
Reason Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk Terminated
Gaviscon Regular Strength Liquid Antacid Cool Mint
Reason Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk Terminated
Gaviscon Regular Strength Liquid Antacid Cool Mint
Reason Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk Terminated
oxyTOCIN 30 Units/500 mL
Reason Subpotent drug - Product did not contain drug.
Class II · Moderate risk Terminated
Lisinopril Tablets
Reason Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets
Reason Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.