Why it was recalled
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Product description
ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-023-10), Rx only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534.
Lot numbers, UPCs & expiration codes
Lot #: a) Z600724, Exp 04/18; Z600725, Exp 04/18
Where it was sold
Nationwide in the USA and Puerto Rico.
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-0605-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 6, 2017
- FDA report date
- Mar 29, 2017
- Quantity
- 9561 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0605-2017, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76673
- Address
- 73 Route 31 N
- Code information
- Lot #: a) Z600724, Exp 04/18; Z600725, Exp 04/18
- Postal code
- 08534-3601
- Report date
- Mar 29, 2017
- Product type
- Drugs
- Recall number
- D-0605-2017
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Product quantity
- 9561 bottles
- Termination date
- Nov 5, 2019
- Reason for recall
- Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-023-10), Rx only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Mar 6, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 21, 2017