EPINEPHrine HCl 16 mg added to 250 mL 0 — Class I drug recall D-1356-2015
Terminated recall by Pharmedium Services, LLC, reported 2015-09-02, distributed nationwide. Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dex
| Recall number | D-1356-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmedium Services, LLC, Lake Forest, IL, United States |
| Recall initiated | 2015-04-13 |
| Classified | 2015-08-25 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2017-01-23 |
| Distributed | Nationwide (US) |
| Quantity | 48 bags |
| Reason classes | specification failure |
| NDC | 61553-0618-61 |
| Lot numbers | 15033060S |
| Expiration dates | 2015-05-03 |
Product
EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6618, NDC# 61553-618-61.
Reason for recall
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
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-1356-2015. 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.