Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16
Reported: December 3, 2014 Initiated: October 1, 2014 #D-0257-2015
Product Description
Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16
Reason for Recall
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Details
- Recalling Firm
- Zydus Pharmaceuticals USA Inc
- Units Affected
- 15,144 bottles
- Distribution
- Nationwide
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 15,144 bottles.
Why was this product recalled? ▼
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 3, 2014. Severity: Low. Recall number: D-0257-2015.
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