Recalls / Class III
Class IIID-1430-2012
Product
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.
- Affected lot / code info
- Lot #: 0375T79384, Exp 05/13; 0375T81348, Exp 09/13; 0375U82277, Exp 01/14
Why it was recalled
Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
Recalling firm
- Firm
- Mallinckrodt Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 172 Railroad Avenue, N/A, Hobart, New York 13788-0416
Distribution
- Quantity
- 41,100 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-05-25
- FDA classified
- 2012-07-31
- Posted by FDA
- 2012-08-08
- Terminated
- 2015-04-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1430-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.