The Recall Desk
SevereFDA (Drugs)·D-1224-2019·Announced 2019-05-01

CMC Enterprise Pharmacy Recalls CeFAZolin Due to Lack of Sterility Assurance

CMC Enterprise Pharmacy is recalling CeFAZolin 1 GM products in North Carolina due to a lack of sterility assurance.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports.

Plain-English summary

CMC Enterprise Pharmacy is recalling specific lots of CeFAZolin 1 GM, available in 100 mL normal saline bags and 10 mL syringes. The recall was initiated because the products lack sterility assurance.

The affected products were distributed in North Carolina. The recall includes 150 bags and 1,369 syringes from various lots with expiration dates ranging from April 13, 2019, to May 26, 2019.

Consumers and healthcare providers should stop using the affected products and contact CMC Enterprise Pharmacy for further instructions or a refund.

The recalled product

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.
Manufacturer
CMC Enterprise Pharmacy
Category
Drug — Antibiotic
Hazard

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: 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

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

See all →

Same hazard · lack of sterility

See all →