Reported Dec 3, 2014 · Terminated
Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd.…
Zydus Pharmaceuticals USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle
- Manufactured byCadila Healthcare Ltd. Ahmedabad, India
- Distributed byZydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16
- Lot codes and dates
Lot #: MP4344Exp 04/2016
- Amount recalled
- 15,144 bottles
Where it was sold
- Nationwide
Why it was recalled
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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