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Actavis South Atlantic LLC

No ongoing recalls currently shown

Based on the official records currently available to Public Health Trace, no recalls naming Actavis South Atlantic LLC are currently shown as ongoing. The 3 records below are historical recall records.

Public Health Trace has 3 recalls naming Actavis South Atlantic LLC as the recalling firm, republished from official FDA and USDA sources.

Recall history - 3 terminated records

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20133
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FDA Recall TerminatedTerminated: April 10, 2014Historical recordClass III

buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.

by Actavis South Atlantic LLC

Reason
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.
Published
September 4, 2013
Distribution
Nationwide

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FDA Recall TerminatedTerminated: May 15, 2014Historical recordClass II

Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA

by Actavis South Atlantic LLC

Reason
Failed Impurity/Degradation Specification; "Related Compound C"
Published
August 7, 2013
Distribution
Nationwide

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FDA Recall TerminatedTerminated: May 9, 2014Historical recordClass III

buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217; NDC 67767-142-30.

by Actavis South Atlantic LLC

Reason
Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
Published
April 24, 2013
Distribution
Nationwide

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Showing 1–3 of 3 results

Some FDA recall records on this page come from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

This page lists recalls that name Actavis South Atlantic LLC as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.