Recalls / Class II
Class IID-1214-2019
Product
Magnesium Sulfate 2 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: EK021807, EK021807A Exp. 5/1/2019; EK261807 Exp. 5/25/2019; EK271808 Exp. 5/26/2019; EK301811 Exp. 5/29/2019; EL261811 Exp. 6/24/2019; EL281808 Exp. 6/26/2019; EA031908 Exp. 7/2/2019; EA111908 Exp. 7/10/2019; EA181907 Exp. 7/17/2019; EA281908 Exp. 7/27/2019; EB071908 Exp. 8/6/2019; EB201909 Exp. 8/19/2019; EC151907 Exp. 9/11/2019.
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
- 6746 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-1214-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.