Why it was recalled
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
Product description
CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC
Lot numbers, UPCs & expiration codes
Codes: L049J12A, L067M12A, L079B13A, L079B13B, L077E13A, L010H13A, L011J13A, L101K13A
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-0037-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 6, 2014
- FDA report date
- Oct 29, 2014
- Quantity
- 181908 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0037-2015, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 69014
- Address
- 120 Vintage Dr NE
- Code information
- Codes: L049J12A, L067M12A, L079B13A, L079B13B, L077E13A, L010H13A, L011J13A, L101K13A
- Postal code
- 35811-8216
- Report date
- Oct 29, 2014
- Product type
- Drugs
- Recall number
- D-0037-2015
- Classification
- Class II
- Recalling firm
- Qualitest Pharmaceuticals
- Product quantity
- 181908 units
- Termination date
- Feb 2, 2016
- Reason for recall
- Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 6, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 21, 2014