Recalls / Class II
Class IID-1213-2019
Product
Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Affected lot / code info
- Lots: EK051810 Exp. 5/4/2019; EK281808 Exp. 5/27/2019; EL101810 Exp. 6/8/2019; EL141807 Exp. 6/12/2019; EA081910 Exp. 7/7/2019; EA161908 Exp. 7/15/2019; EA301908 Exp. 7/29/2019; EB111907 Exp. 8/10/2019; EC041907 Exp. 8/31/2019
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
- 2162 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-1213-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.