Why it was recalled
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of 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-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21
Lot numbers, UPCs & expiration codes
Lot number: C1440512A, 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-057-2013
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Sep 10, 2012
- FDA report date
- Nov 28, 2012
- Quantity
- 14,445 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-057-2013, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Ongoing
- Country
- United States
- Event ID
- 63138
- Address
- 120 Vintage Dr NE
- Code information
- Lot number: C1440512A, Exp 12/13
- Postal code
- 35811-8216
- Report date
- Nov 28, 2012
- Product type
- Drugs
- Recall number
- D-057-2013
- Classification
- Class I
- Recalling firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- Product quantity
- 14,445 bottles
- Reason for recall
- Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of 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-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21
- Distribution pattern
- Nationwide.
- Recall initiation date
- Sep 10, 2012
- Initial firm notification
- Press Release
- Center classification date
- Nov 16, 2012