Drug product
CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE 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 0603-0843-54, OTC
D-0039-2015
Product summary
- Event
- Event 69014
- Status
- Terminated
- Classification
- Class II
- Quantity
- 170113 units
- Official record key
drug-enforcement:D-0039-2015
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: L084G12A, L097K12A, L001B13A, L001B13B, L079D13A, L102G13A, L007J13A
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent