Loading...
Loading...
All product recalls associated with Actavis South Atlantic LLC.
Total Recalls
3
Past Year
0
Class I (Serious)
0
Most Recent
Aug 2013
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.
Failed Impurity/Degradation Specification; "Related Compound C"
Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.