Recalls / Class III
Class IIID-0627-2020
Product
NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
- Affected lot / code info
- Lots: 192930026S Exp. 12/18/19; 192950020S Exp. 12/20/19; 192960029S Exp. 12/21/19; 192970024S Exp. 12/22/19; 193010034S Exp. 12/26/19; 193030036S Exp. 12/28/19; 193040029S Exp. 12/29/19; 193050030S Exp. 1/1/20; 193080025S Exp. 1/2/20; 193080026S Exp. 1/2/20; 193080027S Exp. 1/2/20; 193090017S Exp. 1/3/20; 193090018S Exp. 1/3/20; 193100032S Exp. 1/4/20; 193120028S Exp. 1/8/20; 193160027S Exp. 1/10/20; 193170024S Exp. 1/11/20; 193170025S Exp. 1/11/20; 193180026S Exp. 1/12/20; 193190031S Exp. 1/15/20; 193230027S Exp. 1/17/20; 193240015S Exp. 1/18/20; 193240016S Exp. 1/18/20; 193240017S Exp. 1/18/20; 193240018S Exp. 1/18/20; 193250017S Exp. 1/19/20
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
- 5808 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-0627-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.