Cefazolin Injection (CMC Enterprise) – Sterility Risk (2019)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Brand
CMC Enterprise Pharmacy
Lot Codes / Batch Numbers
Lots: a) ED051904 Exp. 4/14/2019, ED081903 Exp. 4/17/2019, ED091903 Exp. 4/18/2019, ED111903 Exp. 4/20/2019, b) EB271904 Exp. 4/13/2019, EB281904 Exp. 4/14/2019, EC011903 Exp. 4/15/2019, EC051904 Exp. 4/19/2019, EC071904 Exp. 4/21/2019, EC081905 Exp. 4/22/2019, EC121905 Exp. 4/26/2019, EC131903 Exp. 4/27/2019, EC141903 Exp. 4/28/2019, EC151903 Exp. 4/29/2019, EC181904 Exp. 5/2/2019, EC191905 Exp. 5/3/2019, EC211904 Exp. 5/5/2019, EC221905 Exp. 5/6/2019, EC251904 Exp. 5/9/2019, EC271904 Exp. 5/11/2019, EC281904 Exp. 5/12/2019, ED011904 Exp. 5/16/2019, ED021906 Exp. 5/17/2019, ED031904 Exp. 5/18/2019, ED041903 Exp. 5/19/2019, ED051905 Exp. 5/20/2019, ED081904 Exp. 5/23/2019, ED091904 Exp. 5/24/2019, ED101904 Exp. 5/25/2019, ED111904 Exp. 5/26/2019
Products Sold
Lots: a) ED051904 Exp. 4/14/2019; ED081903 Exp. 4/17/2019; ED091903 Exp. 4/18/2019; ED111903 Exp. 4/20/2019; b) EB271904 Exp. 4/13/2019; EB281904 Exp. 4/14/2019; EC011903 Exp. 4/15/2019; EC051904 Exp. 4/19/2019; EC071904 Exp. 4/21/2019; EC081905 Exp. 4/22/2019; EC121905 Exp. 4/26/2019; EC131903 Exp. 4/27/2019; EC141903 Exp. 4/28/2019; EC151903 Exp. 4/29/2019; EC181904 Exp. 5/2/2019; EC191905 Exp. 5/3/2019; EC211904 Exp. 5/5/2019; EC221905 Exp. 5/6/2019; EC251904 Exp. 5/9/2019; EC271904 Exp. 5/11/2019; EC281904 Exp. 5/12/2019; ED011904 Exp. 5/16/2019; ED021906 Exp. 5/17/2019; ED031904 Exp. 5/18/2019; ED041903 Exp. 5/19/2019; ED051905 Exp. 5/20/2019; ED081904 Exp. 5/23/2019; ED091904 Exp. 5/24/2019; ED101904 Exp. 5/25/2019; ED111904 Exp. 5/26/2019
CMC Enterprise Pharmacy is recalling CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 due to Lack of sterility assurance.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of sterility assurance.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NC
Page updated: Jan 21, 2026