Recalls / Class III
Class IIID-0778-2016
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
- Affected lot / code info
- Service Code 2K6127; 15342123S, exp 2/10/2016 15349071S, exp 2/17/2016 and 15351050S, exp 2/19/2016
Why it was recalled
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, Lake Forest, Illinois 60045-2506
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-12-31
- FDA classified
- 2016-03-17
- Posted by FDA
- 2016-03-23
- Terminated
- 2016-04-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0778-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.