Recalls / Class II
Class IID-0038-2015
Product
CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY 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 0603-0842-54, OTC
- Affected lot / code info
- Codes: L084A13A, L095F13A, L027H13A, L102K13A
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.
Recalling firm
- Firm
- Qualitest Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 120 Vintage Dr NE, Huntsville, Alabama 35811-8216
Distribution
- Quantity
- 101208 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-08-06
- FDA classified
- 2014-10-21
- Posted by FDA
- 2014-10-29
- Terminated
- 2016-02-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0038-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.