Recalls / Class I
Class ID-166-2013
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by & Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21.
- Affected lot / code info
- Lot #: 3037841, 3040859, 3042573, Exp 12/13
Why it was recalled
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Recalling firm
- Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, N/A, Rockford, Illinois 61103-1201
Distribution
- Quantity
- 3,407 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-12-14
- FDA classified
- 2013-02-15
- Posted by FDA
- 2013-02-27
- Terminated
- 2016-08-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-166-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.