Recalls / Class III
Class IIID-0626-2020
Product
NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
- Affected lot / code info
- Lot #s: 193040035S, Exp. 12/29/2019; 193120031S, Exp. 01/08/2020; 193150024S, Exp. 01/09/20; 193180030S, Exp. 01/12/20; 193240028S, Exp. 01/18/20; 193250022S, Exp. 01/19/20.
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- 864 bags
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2019-12-16
- FDA classified
- 2019-12-23
- Posted by FDA
- 2020-01-01
- Terminated
- 2021-02-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0626-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.