Class II
Terminated
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.
This recall has been terminated (originally issued August 8, 2012).
- Company
- Mallinckrodt Inc.
- Recall Initiated
- May 25, 2012
- Posted
- August 8, 2012
- Recall Number
- D-1431-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 44,330 bottles
- Firm Location
- Hobart, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
Distribution
Nationwide
Lot / Code Info
Lot #: 0375P76192, Exp 07/12; 0375T80512, Exp 08/13; 0375T81209, Exp 09/13
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