Drug product
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
D-0037-2015
Product summary
- Event
- Event 69014
- Status
- Terminated
- Classification
- Class II
- Quantity
- 181908 units
- Official record key
drug-enforcement:D-0037-2015
Official wording
Reason: 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.
Code information: Codes: L049J12A, L067M12A, L079B13A, L079B13B, L077E13A, L010H13A, L011J13A, L101K13A
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent