Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Protz real protection Antibacterial Hand Sanitizer
Lack of CGMPs:
Class II · Moderate risk
Class II · Moderate risk
Cephalexin for Oral Suspension
Sub-Potent Drug: Out of specification test results for potency (below specification).
Class II · Moderate risk
Cephalexin for Oral Suspension
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
Cephalexin for Oral Suspension
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
Strides Pharma Inc.Potassium Chloride Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets USP
CGMP Deviations
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets USP
CGMP Deviations
Class II · Moderate risk
Zanilast+ Gel Antiseptic Hand Sanitizer
GMP Deviations: Potential to contain 1-propanol.
Class II · Moderate risk
Zanilast+ Gel Antiseptic Hand Sanitizer
GMP Deviations: Potential to contain 1-propanol.
Class II · Moderate risk
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
cGMP Deviations
Class II · Moderate risk
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
cGMP Deviations
Class II · Moderate risk
Buprenorphine HCl Injection
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Class II · Moderate risk
Florance Morris ANTISEPTIC Hand Sanitizer
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
BusPIRone Hydrochloride Tablets
Failed Impurity /Degradation Specifications
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
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
Prednisone Tablets
Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
Class II · Moderate risk
Elitek (rasburicase)
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Class II · Moderate risk
Just Hand Sanitizer
Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class II · Moderate risk
Always Be Clean Hand Sanitizer
Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class II · Moderate risk
UltraCruz Hand Sanitizing Gel Antimicrobial
Subpotent drug
Class II · Moderate risk
Losartan Potassium Tablets USP
Failed Tablet/Capsule Specification; complaint of bulging tablet
Class II · Moderate risk
Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin 1 mg/mL Injectable in 1 mL syringes
Lack of Assurance of Sterility