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.
Reported: March 29, 2017 Initiated: March 6, 2017 #D-0605-2017
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.
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.
Details
- Recalling Firm
- Zydus Pharmaceuticals USA Inc
- Units Affected
- 9561 bottles
- Distribution
- Nationwide in the USA and Puerto Rico.
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 9561 bottles.
Why was this product recalled? ▼
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 29, 2017. Severity: Moderate. Recall number: D-0605-2017.
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