Status
Terminated
Drug Enforcement D-1430-2012
Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
Classification
Class III
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
- 41,100 bottles
- Reason for recall
- Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
- 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-1430-2012
- Event ID
- 61967
- Recall initiation date
- May 25, 2012
- Center classification date
- July 31, 2012
- Code info
- Lot #: 0375T79384, Exp 05/13; 0375T81348, Exp 09/13; 0375U82277, Exp 01/14
- More code info
- —