D-1575-2014 Class II Terminated
FDA drug recall D-1575-2014 was initiated by Apotex Inc. on Mar 24, 2014 and is designated Class II. Reason for recall: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. The recall status is terminated (terminated Sep 23, 2014). Affected quantity: 13,429 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Sep 10, 2014
- Initiation Date
- Mar 24, 2014
- Termination Date
- Sep 23, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,429 bottles
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.
Distribution pattern
Nationwide and Puerto Rico
Code information
Lot # 2A001, Exp. 01/15; Lot # 2C002, Exp. 03/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1575-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026