Recalls / Class II
Class IID-0895-2018
Product
Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
- Affected lot / code info
- Lot # 20180328@19, 20180328@31, 20180328@39, 20180328@49, 20180328@53, 20180328@58, 20180323@9, 20180327@33, Exp 6/26/2018
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
- 492 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-0895-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.