The Recall Desk
SevereFDA (Drugs)·D-1214-2019·Announced 2019-05-01

CMC Enterprise Pharmacy Recalls Magnesium Sulfate Bags Due to Sterility Concerns

CMC Enterprise Pharmacy is recalling 6,746 bags of Magnesium Sulfate 2 GM in NS 50 mL due to a lack of sterility assurance. The affected products were 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 recall is classified as FDA Class II and involves a lack of sterility assurance in a medical drug, which poses a significant risk of infection or serious injury.

Plain-English summary

CMC Enterprise Pharmacy is recalling 6,746 bags of Magnesium Sulfate 2 GM in NS 50 mL. The recall was initiated because of a lack of sterility assurance in the manufacturing process. The affected products were distributed in North Carolina.

The recall covers specific lots with expiration dates ranging from May 1, 2019, to September 11, 2019. The lot numbers include EK021807, EK021807A, EK261807, EK271808, EK301811, EL261811, EL281808, EA031908, EA111908, EA181907, EA281908, EB071908, EB201909, and EC151907.

Healthcare providers and patients should check their inventory for these specific lot numbers and expiration dates. If you have these products, do not use them and contact the recalling firm or your local health authority for further instructions.

The recalled product

Product
Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Manufacturer
CMC Enterprise Pharmacy
Category
Drug — Injectable Medication
Hazard
Affected units
6,746

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 (14)

  • Lots: EK021807
  • EK021807A Exp. 5/1/2019
  • EK261807 Exp. 5/25/2019
  • EK271808 Exp. 5/26/2019
  • EK301811 Exp. 5/29/2019
  • EL261811 Exp. 6/24/2019
  • EL281808 Exp. 6/26/2019
  • EA031908 Exp. 7/2/2019
  • EA111908 Exp. 7/10/2019
  • EA181907 Exp. 7/17/2019
  • EA281908 Exp. 7/27/2019
  • EB071908 Exp. 8/6/2019
  • EB201909 Exp. 8/19/2019
  • EC151907 Exp. 9/11/2019.

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

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Same hazard · lack of sterility

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