Recalls / Class II
Class IID-1218-2019
Product
Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Affected lot / code info
- Lots: EA151909 Exp. 4/15/2019; EA251907 Exp. 4/25/2019; EA301909 Exp. 4/30/2019; EA311911 Exp. 5/1/2019; EB131910 Exp. 5/14/2019; EB201910 Exp. 5/21/2019; EB271909 Exp. 5/28/2019; EC081910 Exp. 6/6/2019; EC131908 Exp. 6/11/2019
Why it was recalled
Lack of sterility assurance.
Recalling firm
- Firm
- CMC Enterprise Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4400 Golf Acres Dr, N/A, Charlotte, North Carolina 28208-5968
Distribution
- Quantity
- 2567 bags
- Distribution pattern
- NC
Timeline
- Recall initiated
- 2019-04-12
- FDA classified
- 2019-04-23
- Posted by FDA
- 2019-05-01
- Terminated
- 2019-10-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1218-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.