Zydus Recalls Paroxetine Tablets Due to Presence of Risperidone
Zydus Pharmaceuticals is recalling Paroxetine tablets because Risperidone tablets were found in the bottles. Consumers should stop using the affected products.
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 source text identifies the presence of a different medication (Risperidone) in Paroxetine bottles, which constitutes a significant injury risk due to potential adverse drug interactions or incorrect dosing, aligning with the rubric for significant injury reports or high-risk contamination.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling Paroxetine Tablets USP, 30 mg, in 30, 500, and 1000 count bottles. The recall was initiated because Risperidone tablets were found in bottles of Paroxetine Tablets. The affected products are prescription-only and were manufactured by Cadila Healthcare Ltd in Ahmedabad, India, and distributed by Zydus Pharmaceuticals USA, Inc. in Pennington, NJ.
The recall covers 19,812 bottles distributed nationwide. The specific lot codes are Z701308, Z701309, and Z701310, all with an expiration date of April 2019. The NDC codes for the affected packages are 68382-099-06, 68382-099-05, and 68382-099-10.
Consumers should stop using the affected Paroxetine tablets and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PAROXETINE (PAROXETINE)
- Brand
- PAROXETINE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Medication
- Affected units
- 19,812
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 (3)
- a) Z701308
- b) Z701309
- c) Z701310 exp April 2019
UPCs (2)
- 0368382098108
- 0368382099105
Distribution
Distributed nationwide across the United States.
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