Recalls / Class II
Class IID-1215-2019
Product
Magnesium Sulfate 4 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: EK131812 Exp. 5/12/2019; EL051809 Exp. 6/3/2019; EL111808 Exp. 6/9/2019; EL141808 Exp. 6/12/2019; EA031909 Exp. 7/2/2019; EA141909 Exp. 7/13/2019; EA311910 Exp. 7/30/2019; EB061909 Exp. 8/5/2019; EC121909 Exp. 9/8/2019; EC251910 Exp. 9/21/2019
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
- 3007 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-1215-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.