The Recall Desk
SevereFDA (Drugs)·D-1238-2019·Announced 2019-05-01

Vancomycin Bags Recalled Due to Lack of Sterility Assurance

CMC Enterprise Pharmacy is recalling 118 bags of Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL due to 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 or high-risk contamination.

Plain-English summary

CMC Enterprise Pharmacy is recalling 118 bags of Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL. The recall was initiated due to a lack of sterility assurance for the product.

The affected product was distributed in North Carolina. The specific lots involved are ED041918, ED051917, ED081917, ED091917, ED1019117, and ED111915, with expiration dates ranging from April 13, 2019, to April 20, 2019.

Consumers and healthcare providers should stop using the recalled product and contact the pharmacy or their healthcare provider for further instructions.

The recalled product

Product
Vancomycin 1750 mg in 0.9% Sodium Chloride 500 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
118

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: ED041918 Exp. 4/13/2019
  • ED051917 Exp. 4/14/2019
  • ED081917 Exp. 4/17/2019j
  • ED091917 Exp. 4/18/2019
  • ED1019117 Exp. 4/19/2019
  • ED111915 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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