FDAFDA · Food and drugs·Recall number D-1430-2012
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.
Published August 8, 2012 · Recall initiated: May 25, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mallinckrodt Inc.
- Distributor
- Nationwide
- Lot
- Lot #: 0375T79384, Exp 05/13; 0375T81348, Exp 09/13; 0375U82277, Exp 01/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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