Drug 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
D-0778-2016
Product summary
- Event
- Event 72973
- Status
- Terminated
- Classification
- Class III
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0778-2016
Official wording
Reason: Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Code information: Service Code 2K6127; 15342123S, exp 2/10/2016 15349071S, exp 2/17/2016 and 15351050S, exp 2/19/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent