Actavis South Atlantic recalls
FDA enforcement reports naming Actavis South Atlantic LLC as the recalling firm.
- Recall reports
- 3
- Class I (serious)
- 0
- Most recent report
- Sep 4, 2013
- Sep 4, 2013buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bot…Drug · Actavis South Atlantic LLCFailed 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…Class III
- Aug 7, 2013Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx OnlyDrug · Actavis South Atlantic LLCFailed Impurity/Degradation Specification; "Related Compound C"Class II
- Apr 24, 2013buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bott…Drug · Actavis South Atlantic LLCFailed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.Class III