Status
Terminated
Drug Enforcement D-1431-2012
CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
Classification
Class II
Report Date
August 8, 2012
Termination Date
April 17, 2015
Product Information
- Product description
- Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
- Product quantity
- 44,330 bottles
- Reason for recall
- CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Mallinckrodt Inc.
- Address
-
172 Railroad Avenue, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1431-2012
- Event ID
- 61967
- Recall initiation date
- May 25, 2012
- Center classification date
- July 31, 2012
- Code info
- Lot #: 0375P76192, Exp 07/12; 0375T80512, Exp 08/13; 0375T81209, Exp 09/13
- More code info
- —