D-0778-2016 Class III Terminated
FDA drug recall D-0778-2016 was initiated by Pharmedium Services, LLC on Dec 31, 2015 and is designated Class III. Reason for recall: Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration The recall status is terminated (terminated Apr 6, 2016).
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 23, 2016
- Initiation Date
- Dec 31, 2015
- Termination Date
- Apr 6, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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
Distribution Pattern
Nationwide
Code Information
Service Code 2K6127; 15342123S, exp 2/10/2016 15349071S, exp 2/17/2016 and 15351050S, exp 2/19/2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0778-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026