Skip to content
Recall Observatory FDA recall evidence

Drug product

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

D-1575-2014

March 24, 2014

Class II

Product summary

Firm
Apotex Inc.
Event
Event 68967
Status
Terminated
Classification
Class II
Quantity
13,429 bottles
Official record key
drug-enforcement:D-1575-2014

Official wording

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

Code information: Lot # 2A001, Exp. 01/15; Lot # 2C002, Exp. 03/15

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination