Recalls / Class II
Class IID-1217-2019
Product
NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Affected lot / code info
- Lots: EA161909 Exp. 4/16/2019; EA211907 Exp. 4/21/2019; EB041906 Exp. 5/5/2019; EB111908 Exp. 5/12/2019; EB181907 Exp. 5/19/2019; EB251910 Exp. 5/26/2019; EC111908 Exp. 6/9/2019; EC201909 Exp. 6/18/2019; EC261909 Exp. 6/24/2019; EC271919 Exp. 6/25/2019
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
- 1783 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-1217-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.