Why it was recalled
Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
Product description
ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC 68382-022-01
Lot numbers, UPCs & expiration codes
MP2292 Exp. 01/16
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0007-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 5, 2014
- FDA report date
- Oct 15, 2014
- Quantity
- 5400 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0007-2015, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 68988
- Address
- 73 Route 31 N
- Code information
- MP2292 Exp. 01/16
- Postal code
- 08534-3601
- Report date
- Oct 15, 2014
- Product type
- Drugs
- Recall number
- D-0007-2015
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Product quantity
- 5400 bottles
- Termination date
- Sep 22, 2017
- Reason for recall
- Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC 68382-022-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 5, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 3, 2014