Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
CGMP Deviations
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Lack of Assurance of Sterility: Leaking vials
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Discoloration: Brownish tablets
Product is labeled as gluten free but consumer advocacy group testing revealed results above 20ppm for gluten.
Lack of Assurance of Sterility
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.