Recalls / Class II
Class IID-0899-2018
Product
Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
- Affected lot / code info
- Lot # 1218000930, 1218000946, 1218001058, 1218001077, 1218001169, 1218001170, 1218001190, 1218001191, 1218001206, 1218001317, Exp 06/18/2018-07/11/2018
Why it was recalled
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Recalling firm
- Firm
- SCA Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 755 Rainbow Rd Ste B, Windsor, Connecticut 06095-1024
Distribution
- Quantity
- 1,882 bags
- Distribution pattern
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2018-06-14
- FDA classified
- 2018-07-02
- Posted by FDA
- 2018-07-11
- Terminated
- 2019-02-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0899-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.