CLASS II Drug recall · Reported 29 Oct 2014 · FDA Enforcement Report
Children's Q-pap, Acetaminophen, Oral Suspension recalled
Qualitest Pharmaceuticals is recalling Children's Q-pap, Acetaminophen, Oral Suspension, Grape Flavor, Active ingredient (in, distributed nationwide in the US. The recall was initiated on 6 Aug 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0039-2015
- FDA event ID
- 69014
- Recalling firm
- Qualitest Pharmaceuticals, Huntsville, AL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2014
- FDA classified
- 21 Oct 2014
- Reported
- 29 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 6 Aug 2014 | Recall initiated by company | |
| 21 Oct 2014 | Classified by FDA | +76 days |
| 29 Oct 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it 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.
Which lots are affected?
Codes: L084G12A, L097K12A, L001B13A, L001B13B, L079D13A, L102G13A, L007J13A
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 69014| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Children's Q-pap, Acetaminophen, Oral Suspension recalled | Qualitest Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS II | Children's Q-pap, Acetaminophen, Oral Suspension recalled | Qualitest Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Qualitest Pharmaceuticals
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Allopurinol Tablets, USP, 300 mg recalled by Qualitest PharmaceuticalsAllopurinol | Qualitest Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | HydrOXYzine Hydrochloride Tablets, USP 25 mg recalled | Qualitest Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Disulfiram tablets, USP, 500 mg recalled by Qualitest Pharmaceuticals | Qualitest Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Promethazine VC With Codeine Syrup, Each contains recalled | Qualitest Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Promethazine DM Syrup (Promethazine Hydrochloride recalled | Qualitest Pharmaceuticals | Particulate Matter | Nationwide |
Other Children's Q-pap recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Children's Q-pap, Acetaminophen, Oral Suspension recalled | Qualitest Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Children's Q-pap, Acetaminophen, Oral Suspension recalled | Qualitest Pharmaceuticals | Potency & Assay | Nationwide |