FDA-Drug2014-09-10Class II

PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5

Apotex Inc.
Hazard

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

Sold states
Nationwide and Puerto Rico
Affected count
13,429 bottles
Manufactured in
150 Signet Drive, Toronto, Canada
Products
PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1575-2014

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