FDAFDA · Food and drugs·Recall number D-1578-2014
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
Published September 10, 2014 · Recall initiated: March 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PAXIL
- Manufacturer
- Apotex Inc.
- Distributor
- Nationwide and Puerto Rico
- UPC
- 0360505366835
- Lot
- Lot # 2F004, Exp. 06/15
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Canada
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