CHILDREN'S IBUPROFEN — Class II drug recall D-1062-2014
Terminated recall by Central Shared Services dba Parallon, reported 2014-02-12, distributed in GA, KY, TN. CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received rega
| Recall number | D-1062-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Central Shared Services dba Parallon, Nashville, TN, United States |
| Recall initiated | 2013-08-23 |
| Classified | 2014-02-04 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-02-04 |
| Distributed | GA, KY, TN |
| Quantity | 3,764 cups |
| Reason classes | cgmp |
Product
CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH
Reason for recall
CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.
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-1062-2014. 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.