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
FDA Drug Recalls
14,450 recalls · Class II, newest first
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
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
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
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 Completed
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
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.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Some bottles may contain mixed strengths of the product.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Some bottles may contain mixed strengths of the product.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Some bottles may contain mixed strengths of the product.
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets
Reason Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Class II · Moderate risk Ongoing
Maximum Strength Lidocaine Cold & Hot Patch
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk Ongoing
Mencaine
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk Ongoing
LidoPro
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk Ongoing
LidoPatch
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk Terminated
EcoLips Sport Lip Balm
Reason Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
Class II · Moderate risk Terminated
Estriol USP Micronized 5 G
Reason Failed impurities/ degradation specifications: Out of specification for organic impurities.
Class II · Moderate risk Terminated
Doxycycline Hyclate tablets USP
Reason Failed dissolution specifications
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets USP
Reason Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.