Recalls / Class II
Class IID-1225-2019
Product
CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Affected lot / code info
- Lots: a) ED041904 Exp. 4/13/2019; ED051906 Exp. 4/14/2019; ED081905 Exp. 4/17/2019; ED091905 Exp. 4/18/2019; ED111905 Exp. 4/20/2019; b) EB271906 Exp. 4/13/2019; EB281906 Exp. 4/14/2019; EC051906 Exp. 4/19/2019; EC061905 Exp. 4/20/2019; EC071906 Exp. 4/21/2019; EC081907 Exp. 4/22/2019; EC111905 Exp. 4/25/2019; EC121907 Exp. 4/26/2019; EC131905 Exp. 4/27/2019; EC141905 Exp. 4/28/2019; EC151905 Exp. 4/29/2019; EC181906 Exp. 5/2/2019; EC191907 Exp. 5/3/2019; EC201905 Exp. 5/4/2019; EC211906 Exp. 5/5/2019; EC221907 Exp. 5/6/2019; EC251906 Exp. 5/9/2019; EC261906 Exp. 5/10/2019; EC271906 Exp. 5/11/2019; EC281906 Exp. 5/12/2019; EC011904 Exp. 5/16/2019; ED021908 Exp. 5/17/2019; ED031906 Exp. 05/18/2019; ED041905 Exp. 5/19/2019; ED051907 Exp. 5/20/2019; ED081906 Exp. 5/23/2019; ED091905 Exp. 5/24/2019; ED101906 Exp. 5/25/2019; ED111906 Exp. 5/26/2019
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
- a) 1357 bags; b) 6895 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-1225-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.