Why it was recalled
Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
Product description
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 numbers, UPCs & expiration codes
Lot #: 0375T79384, Exp 05/13; 0375T81348, Exp 09/13; 0375U82277, Exp 01/14
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-1430-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 25, 2012
- FDA report date
- Aug 8, 2012
- Quantity
- 41,100 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mallinckrodt Inc.
Original FDA data
Every field from FDA enforcement report D-1430-2012, exactly as published.
Show all FDA fields
- City
- Hobart
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 61967
- Address
- 172 Railroad Avenue
- Code information
- Lot #: 0375T79384, Exp 05/13; 0375T81348, Exp 09/13; 0375U82277, Exp 01/14
- Postal code
- 13788-0416
- Report date
- Aug 8, 2012
- Product type
- Drugs
- Recall number
- D-1430-2012
- Classification
- Class III
- Recalling firm
- Mallinckrodt Inc.
- Product quantity
- 41,100 bottles
- Termination date
- Apr 17, 2015
- Reason for recall
- Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- May 25, 2012
- Initial firm notification
- Letter
- Center classification date
- Jul 31, 2012