Apotex Recalls PAXIL Tablets Due to Chemical Contamination
Apotex Inc. is recalling PAXIL (Paroxetine HCL) 40 mg tablets due to contamination 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 severity score (4) under the rubric, as it involves a chemical contamination that could cause serious health consequences.
Plain-English summary
Apotex Inc. is recalling PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottles, NDC 60505-3666-3. The recall involves Lot # 2ZP3908 with an expiration date of 05/15. The product was manufactured by GlaxoSmithKline in RTP, NC, for Apotex Corp. in Weston, FL.
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 a chemical contamination issue.
The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment.
The recalled product
- Product
- PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3666-3
- Manufacturer
- Apotex Inc.
- Category
- Drug — Prescription Medication
- Hazard
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 (2)
- Lot # 2ZP3908
- Exp. 05/15
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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