FDA Drug recall D-1575-2014
PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709
- FDA Drug
- Class II
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class II recall of PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709 by Apotex, citing chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1575-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-24 |
| Published | 2014-09-10 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Apotex |
| Distribution | US |
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
Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Identifiers
| code_info | Lot # 2A001, Exp. 01/15; Lot # 2C002, Exp. 03/15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1575-2014%22
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