Apotex Recalls PAXIL Oral Suspension Due to Chemical Contamination
Apotex Inc. is recalling PAXIL (Paroxetine HCL) Oral Suspension because it was manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the presence of chemical contamination in a prescription medication.
Plain-English summary
Apotex Inc. is recalling 13,429 bottles of PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL, 250 mL bottles. The product is distributed nationwide and in Puerto Rico. The affected lots are # 2A001 (Exp. 01/15) and # 2C002 (Exp. 03/15).
The recall was initiated because the product was manufactured with active pharmaceutical ingredient (API) batches that were contaminated with residual materials and solvents. This is classified as an FDA Class II recall.
Consumers should check their medication for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- 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
- Manufacturer
- Apotex Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 13,429
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot # 2A001
- Exp. 01/15
- Lot # 2C002
- Exp. 03/15
Distribution
Part of a larger recall action
This product is one of 9 recalled by Apotex Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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