Zydus Recalls Atenolol Tablets Due to Foreign Paroxetine Tablet Presence
Zydus Pharmaceuticals USA Inc. is recalling specific lots of Atenolol 50 mg tablets because a customer reported finding a paroxetine 20 mg tablet in a bottle.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of a foreign drug tablet (paroxetine) in a beta-blocker (atenolol) poses a risk of harm through unintended medication administration, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling Atenolol Tablets, USP, 50 mg, manufactured by Cadila Healthcare Ltd. in India and distributed by Zydus Pharmaceuticals USA Inc. in Pennington, NJ. The recall is initiated due to a customer complaint that a bottle of the recalled atenolol tablets contained a paroxetine 20 mg tablet.
The affected product is packaged in 100-count bottles (NDC 68382-023-01) and 1000-count bottles (NDC 68382-023-10). The specific lots involved are Z600724 and Z600725, both with an expiration date of 04/18. A total of 9,561 bottles were distributed nationwide in the USA and Puerto Rico.
Consumers should check their medication for these specific lot numbers and expiration dates. If the medication 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
- ATENOLOL (ATENOLOL)
- Brand
- ATENOLOL
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Drug
- Affected units
- 9,561
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)
- Lot #: a) Z600724
- Exp 04/18
- Z600725
Distribution
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