Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
Protz real protection Antibacterial Hand Sanitizer
Reason Lack of CGMPs:
Class II · Moderate risk Terminated
V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz
Reason Lack of CGMPs:
Class II · Moderate risk Terminated
Cephalexin for Oral Suspension
Reason Sub-Potent Drug: Out of specification test results for potency (below specification).
Class II · Moderate risk Terminated
Cephalexin for Oral Suspension
Reason CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Class II · Moderate risk Terminated
Cephalexin for Oral Suspension
Reason CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Class II · Moderate risk Terminated
Strides Pharma Inc.Potassium Chloride Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets USP
Reason CGMP Deviations
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets USP
Reason CGMP Deviations
Class II · Moderate risk Terminated
Zanilast+ Gel Antiseptic Hand Sanitizer
Reason GMP Deviations: Potential to contain 1-propanol.
Class II · Moderate risk Terminated
Zanilast+ Gel Antiseptic Hand Sanitizer
Reason GMP Deviations: Potential to contain 1-propanol.
Class II · Moderate risk Terminated
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
Reason cGMP Deviations
Class II · Moderate risk Terminated
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
Reason cGMP Deviations
Class II · Moderate risk Terminated
Buprenorphine HCl Injection
Reason Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Class II · Moderate risk Terminated
Florance Morris ANTISEPTIC Hand Sanitizer
Reason CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class II · Moderate risk Terminated
BusPIRone Hydrochloride Tablets
Reason Failed Impurity /Degradation Specifications
Class II · Moderate risk Terminated
Sulfamethoxazole and Trimethoprim Tablets
Reason Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Class II · Moderate risk Terminated
Prednisone Tablets
Reason Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg