Status
Terminated
Drug Enforcement D-66403-001
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Classification
Class II
Report Date
November 13, 2013
Termination Date
July 23, 2015
Product Information
- Product description
- Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
- Product quantity
- 37,752 bottles
- Reason for recall
- CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Address
-
781 Chestnut Ridge Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-66403-001
- Event ID
- 66403
- Recall initiation date
- September 13, 2013
- Center classification date
- November 4, 2013
- Code info
- Lot #: a) 3037907, 3040106; b) 3037907, 3040106, 3044357
- More code info
- —