The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1225-2019·Announced 2019-05-01

CMC Enterprise Pharmacy Recalls CeFAZolin Due to Lack of Sterility Assurance

CMC Enterprise Pharmacy is recalling specific lots of CeFAZolin 2 GM in bags and syringes due to a lack of sterility assurance. The products were distributed in North Carolina.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in injectable medications.

Plain-English summary

CMC Enterprise Pharmacy is recalling specific lots of CeFAZolin 2 GM, available in 100 mL bags and 100 mg/mL syringes. The recall is being conducted because the products lack sterility assurance.

The affected products were distributed in North Carolina. The recall includes 1,357 bags and 6,895 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 lots and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

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.
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) 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

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 →

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