FDA Drug recall D-0777-2016
NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium…
- FDA Drug
- Class III
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class III recall of NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium… 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-0777-2016 |
| 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, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61
Reason
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Identifiers
| code_info | Service Code 2K6134; 15342084S, 15342191S, 15342223S, 15342224S, 15342225S, and 15342226S, exp 2/10/2016; 15343025S,…Service Code 2K6134; 15342084S, 15342191S, 15342223S, 15342224S, 15342225S, and 15342226S, exp 2/10/2016; 15343025S, 15343026S, 15343129S, and 15343131S, exp 2/11/2016; 15344157S, 15344160S, and 15344209S, exp 2/12/2016; 15345036S, 15345104S, 15345106S, and 15345142S, exp 2/13/2016; 15346015S, 15346016S, 15346017S, 15346018S, 15346019S, 15346020S, 15346022S, and 15346023S, exp 2/14/2016; 15348152S, and 15348197S, exp 2/16/2016 15350046S, and 15350154S, exp 2/18/2016 |
|---|
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-0777-2016%22
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