Class II
Terminated
Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11); 10 blister packs per carton (NDC 68084-506-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
This recall has been terminated (originally issued July 15, 2015).
- Company
- American Health Packaging
- Recall Initiated
- June 1, 2015
- Posted
- July 15, 2015
- Recall Number
- D-1220-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,745 cartons
- Firm Location
- Columbus, OH, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Distribution
Nationwide
Lot / Code Info
Lot#: 131953, Exp 07/31/2015
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