Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Product description
ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Lot numbers, UPCs & expiration codes
Lot #: a) L140H13B, Exp. 03/15; L001D14A. Exp. 08/15; b) L140H13A, Exp. 03/15; L205K13A, Exp. 05/15; L019L13A, L020L13A, Exp. 06/15; L001D14B, 08/15; L091D14A, Exp. 10/15
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-0331-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 22, 2014
- FDA report date
- Jan 14, 2015
- Quantity
- a) 3936 bottles; b) 84420 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0331-2015, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 70168
- Address
- 120 Vintage Dr NE
- Code information
- Lot #: a) L140H13B, Exp. 03/15; L001D14A. Exp. 08/15; b) L140H13A, Exp. 03/15; L205K13A, Exp. 05/15; L019L13A, L020L13A, Exp. 06/15; L001D14B, 08/15; L091D14A, Exp. 10/15
- Postal code
- 35811-8216
- Report date
- Jan 14, 2015
- Product type
- Drugs
- Recall number
- D-0331-2015
- Classification
- Class III
- Recalling firm
- Qualitest Pharmaceuticals
- Product quantity
- a) 3936 bottles; b) 84420 bottles
- Termination date
- Feb 1, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 22, 2014
- Initial firm notification
- Letter
- Center classification date
- Jan 6, 2015