PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL recall: Contamination
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
Why was PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL recalled?
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 2A001, Exp. 01/15; Lot # 2C002, Exp. 03/15
- 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
- Recalling firm
- Apotex Inc.
- Quantity
- 13,429 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- September 10, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)