PlainRecalls
FDA Drug Moderate Class II Terminated

PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3669-3

Reported: September 10, 2014 Initiated: March 24, 2014 #D-1578-2014

Product Description

PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3669-3

Reason for Recall

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Details

Recalling Firm
Apotex Inc.
Distribution
Nationwide and Puerto Rico
Location
Toronto

Frequently Asked Questions

What product was recalled?
PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3669-3. Recalled by Apotex Inc..
Why was this product recalled?
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 10, 2014. Severity: Moderate. Recall number: D-1578-2014.