Class II
Terminated
Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
This recall has been terminated (originally issued November 13, 2013).
- Company
- Mylan Pharmaceuticals Inc.
- Recall Initiated
- September 13, 2013
- Posted
- November 13, 2013
- Recall Number
- D-66403-012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 101,450 bottles
- Firm Location
- Morgantown, WV, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: a) 3038984, 3038985, 3038986, 3041484, 3041485; b) 3036828, 3036829, 3036830, 3036831, 3036832, 3038987, 3038988, 3038989, 3038990, 3041480, 3041481, 3041482, 3041483, 3044522, 3044525
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