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
Reported: September 10, 2014 Initiated: March 24, 2014 #D-1575-2014
Product Description
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
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.
- Units Affected
- 13,429 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Toronto
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Apotex Inc.. Units affected: 13,429 bottles.
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-1575-2014.
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