NORepinephrine Bitartrate — Class III drug recall D-0778-2016
Terminated recall by Pharmedium Services, LLC, reported 2016-03-23, distributed nationwide. Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
| Recall number | D-0778-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmedium Services, LLC, Lake Forest, IL, United States |
| Recall initiated | 2015-12-31 |
| Classified | 2016-03-17 |
| Reported by FDA | 2016-03-23 |
| Terminated | 2016-04-06 |
| Distributed | Nationwide (US) |
| Reason classes | potency |
| NDC | 61553-0127-61 |
| Expiration dates | 2016-02-10, 2016-02-17, 2016-02-19 |
Product
NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61
Reason for recall
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
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-0778-2016. 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.