Recalls / Class III
Class IIID-0777-2016
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
- Affected lot / code info
- 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
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
- Quantity
- 6,816 bags
- 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-0777-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.