ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP — Class III drug recall D-0331-2015
Terminated recall by Qualitest Pharmaceuticals, reported 2015-01-14, distributed nationwide. Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Amino
| Recall number | D-0331-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualitest Pharmaceuticals, Huntsville, AL, United States |
| Recall initiated | 2014-12-22 |
| Classified | 2015-01-06 |
| Reported by FDA | 2015-01-14 |
| Terminated | 2016-02-01 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00603-9013-54, 00603-9013-58 |
Product
ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Reason for recall
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0331-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.