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 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.
Brand
CMC Enterprise Pharmacy
Lot Codes / Batch Numbers
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
Products Sold
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
CMC Enterprise Pharmacy is recalling CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 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