Status
Terminated
Drug Enforcement D-1064-2013
CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.
Classification
Class II
Report Date
October 9, 2013
Termination Date
November 20, 2014
Product Information
- Product description
- Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8.
- Product quantity
- 28,387 bottles
- Reason for recall
- CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide.
Location & Firm
- Recalling firm
- Marlex Pharmaceuticals, Inc.
- Address
-
50 McCullough Dr, Southgate Industrial Park
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1064-2013
- Event ID
- 65967
- Recall initiation date
- August 8, 2013
- Center classification date
- September 27, 2013
- Code info
- Lot #: 3213, Exp 12/13
- More code info
- —