The Recall Desk
HighFDA (Drugs)·D-1226-2019·Announced 2019-05-01

Cefazolin Syringes Recalled Due to Lack of Sterility Assurance

CMC Enterprise Pharmacy is recalling 475 cefazolin syringes distributed in North Carolina because they lack sterility assurance.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (lack of sterility assurance) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

CMC Enterprise Pharmacy is recalling 475 syringes of Cefazolin 3 gm 100 mg/mL, 30 mL. The recall is due to a lack of sterility assurance. The product was distributed in North Carolina.

The affected lots include EB281907, EC011905, EC071907, EC081908, EC131906, EC141906, EC151919, EC181907, EC201906, EC211907, EC221908, EC251907, EC261907, EC271907, EC281907, EC011907, ED021909, ED031907, ED041906, ED051908, ED081907, and ED091907. These lots have expiration dates ranging from April 14, 2019, to May 24, 2019.

Consumers and healthcare providers should stop using the recalled product and contact the recalling firm for further instructions.

The recalled product

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.
Manufacturer
CMC Enterprise Pharmacy
Category
Drug — Antibiotic
Hazard
Affected units
475

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 32 recalled by CMC Enterprise Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 32 products in this recall →

Related recalls

Same manufacturer · CMC Enterprise Pharmacy

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Same hazard · lack of sterility

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