FDA Drug recall D-0331-2015
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…
- FDA Drug
- Class III
- terminated
- Published 2015-01-14
On 2015-01-14 the FDA classified a Class III recall of 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… by Qualitest Pharmaceuticals, citing failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0331-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-12-22 |
| Published | 2015-01-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Qualitest Pharmaceuticals |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Identifiers
| upc | 306039013548 |
|---|---|
| upc | 306039013586 |
| code_info | Lot #: a) L140H13B, Exp. 03/15; L001D14A. Exp. 08/15; b) L140H13A, Exp. 03/15; L205K13A, Exp. 05/15; L019L13A, L020L13A…Lot #: a) L140H13B, Exp. 03/15; L001D14A. Exp. 08/15; b) L140H13A, Exp. 03/15; L205K13A, Exp. 05/15; L019L13A, L020L13A, Exp. 06/15; L001D14B, 08/15; L091D14A, Exp. 10/15 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0331-2015%22
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