FDA Drug recall D-0778-2016
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, PharM…
- FDA Drug
- Class III
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class III recall of 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, PharM… by Pharmedium Services, citing subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0778-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-12-31 |
| Published | 2016-03-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pharmedium Services |
| Distribution | US |
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
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Identifiers
| code_info | Service Code 2K6127; 15342123S, exp 2/10/2016 15349071S, exp 2/17/2016 and 15351050S, exp 2/19/2016 |
|---|
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-0778-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.