Reported Aug 8, 2012 · 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.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mallinckrodt Inc. · 172 Railroad Avenue · Hobart, NY · 13788-0416
Is this the product you have?
- 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.
- Lot codes and dates
Lot #: 0375P76192Exp 07/120375T80512Exp 08/130375T81209Exp 09/13
- Amount recalled
- 44,330 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
This product could cause temporary or reversible health problems — stop using it.
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