Recalls / Class II
Class IID-1226-2019
Product
CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Affected lot / code info
- Lots: EB281907 Exp. 4/14/2019; EC011905 Exp. 4/15/2019; EC071907 Exp. 4/21/2019; EC081908 Exp. 4/22/2019; EC131906 Exp. 4/27/2019; EC141906 Exp. 4/28/2019; EC151919 Exp. 4/29/2019; EC181907 Exp. 5/2/2019; EC201906 Exp. 5/4/2019; EC211907 Exp. 5/5/2019; EC221908 Exp. 5/6/2019; EC251907 Exp. 5/9/2019; EC261907 Exp. 5/10/2019; EC271907 Exp. 5/11/2019; EC281907 Exp. 5/12/2019; EC011907 Exp. 5/16/2019; ED021909 Exp. 5/17/2019; ED031907 Exp. 5/18/2019; ED041906 Exp. 5/19/2019; ED051908 Exp. 5/20/2019; ED081907 Exp. 5/23/2019; ED091907 Exp. 5/24/2019
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
- 475 syringes
- 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-1226-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.