Recalls / Class III
Class IIID-0257-2015
Product
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
- Brand name
- Amlodipine Besylate
- Generic name
- Amlodipine Besylate
- Active ingredient
- Amlodipine Besylate
- Route
- Oral
- NDCs
- 68382-121, 68382-122, 68382-123
- FDA application
- ANDA078226
- Affected lot / code info
- Lot #: MP4344, Exp 04/2016
Why it was recalled
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 15,144 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-10-01
- FDA classified
- 2014-11-21
- Posted by FDA
- 2014-12-03
- Terminated
- 2016-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0257-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.