100 mcg / mL Phenylephrine HCl — Class II drug recall D-0424-2018
Terminated recall by PharMEDium Services, LLC, reported 2018-02-21, distributed in FL, NY, SC, WA. Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing an
| Recall number | D-0424-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PharMEDium Services, LLC, Dayton, NJ, United States |
| Recall initiated | 2018-02-05 |
| Classified | 2018-03-29 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2018-04-24 |
| Distributed | FL, NY, SC, WA |
| Quantity | 500 syringes |
| Reason classes | sterility, specification failure |
| Lot numbers | 180080063D |
| Expiration dates | 2018-04-09 |
Product
100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
Reason for recall
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
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-0424-2018. 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.