Zydus Recalls Paroxetine Tablets Due to Foreign Risperidone Contamination
Zydus Pharmaceuticals is recalling 44,800 bottles of 30mg Paroxetine tablets because foreign Risperidone tablets were found in the packaging.
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 and involves the presence of a foreign drug (risperidone) in a paroxetine bottle, which poses a significant risk of serious injury or adverse health consequences due to unintended medication intake.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling 44,800 bottles of Paroxetine tablets USP, 30mg, 30-count. The recall was initiated because foreign Risperidone tablets were found in bottles of Paroxetine tablets. The affected product is Lot # Z701133 with an expiration date of 03/19, distributed nationwide within the United States.
The product is a prescription-only medication manufactured by Cadila Healthcare Ltd in Ahmedabad, India, and distributed by Zydus Pharmaceuticals USA, Inc. in Pennington, NJ. The specific NDC for the recalled item is 68382-099-06.
Consumers who have this specific lot of Paroxetine should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class II, indicating a reasonable probability that temporary or medically reversible adverse health consequences could occur.
The recalled product
- Product
- PAROXETINE (PAROXETINE)
- Brand
- PAROXETINE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Medication
- Affected units
- 44,800
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 #: Z701133
- Exp 03/19
UPCs (3)
- 0368382098108
- 0368382099105
- 368382099068
Distribution
Distributed nationwide across the United States.
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