Why it was recalled
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 3037841, 3040859, 3042573, Exp 12/13
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-166-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 14, 2012
- FDA report date
- Feb 27, 2013
- Quantity
- 3,407 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Original FDA data
Every field from FDA enforcement report D-166-2013, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 63899
- Address
- 1718 Northrock Ct
- Code information
- Lot #: 3037841, 3040859, 3042573, Exp 12/13
- Postal code
- 61103-1201
- Report date
- Feb 27, 2013
- Product type
- Drugs
- Recall number
- D-166-2013
- Classification
- Class I
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Product quantity
- 3,407 cartons
- Termination date
- Aug 9, 2016
- Reason for recall
- Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 14, 2012
- Initial firm notification
- Letter
- Center classification date
- Feb 15, 2013