The Recall Desk
SevereFDA (Drugs)·D-1236-2019·Announced 2019-05-01

Vancomycin IV Bags Recalled Due to Lack of Sterility Assurance

CMC Enterprise Pharmacy is recalling 737 bags of Vancomycin 1250 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.

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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in an injectable medication, which poses a significant risk of infection or serious injury.

Plain-English summary

CMC Enterprise Pharmacy is recalling 737 bags of Vancomycin 1250 mg in NS 250 mL. The recall is being conducted because of a lack of sterility assurance for the product. The affected lots were manufactured by Enterprise Pharmacy in Charlotte, North Carolina.

The recall covers specific lots with expiration dates ranging from April 13, 2019, to April 20, 2019. The distribution pattern for these products is limited to North Carolina. The agency has classified this recall as Class II.

Consumers and healthcare providers should stop using the affected products and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
Vancomycin 1250 mg in NS 250 mL bag, 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
737

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 (6)

  • Lots: ED041915 Exp. 4/13/2019
  • ED051915 Exp. 4/14/2019
  • ED081915 Exp. 4/17/2019
  • ED091915 Exp. 4/18/2019
  • ED101915 Exp. 4/19/2019
  • ED111913 Exp. 4/20/2019

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 · sterility

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