Class II · Moderate risk
Kollidon CL-M Crospovidone Ph.Eur.Type B
Cross contamination: the excipient was found to be contaminated with theophylline.
FDA Drug Recalls
5 recalls · Class II, newest first
Class II · Moderate risk
SYP Health Hand Sanitizer Alcohol Gel
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk
HAND SANITIZER Non-sterile Solution 70% Topical Solution
cGMP deviations
Class II · Moderate risk
Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol
cGMP deviations
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels