The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1213-2019·Announced 2019-05-01

CMC Enterprise Pharmacy Recalls Magnesium Sulfate Bags Due to Sterility Concerns

CMC Enterprise Pharmacy is recalling 2,162 bags of Magnesium Sulfate 1 GM in NS 50 mL due to a lack of sterility assurance. The affected 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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a drug with a sterility defect (a significant injury risk) corresponds to a score of 4 (Severe).

Plain-English summary

CMC Enterprise Pharmacy is recalling 2,162 bags of Magnesium Sulfate 1 GM in NS 50 mL. The recall is being conducted because of a lack of sterility assurance for the product. The affected bags were manufactured by Enterprise Pharmacy in Charlotte, North Carolina.

The recall covers specific lots with expiration dates ranging from May 4, 2019, to August 31, 2019. The affected lots include EK051810, EK281808, EL101810, EL141807, EA081910, EA161908, EA301908, EB111907, and EC041907. The products were distributed in North Carolina.

The FDA has classified this recall as Class II, which means that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should stop using the affected products and contact the recalling firm for further instructions.

The recalled product

Product
Magnesium Sulfate 1 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 — IV Solution
Hazard
Affected units
2,162

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 (9)

  • Lots: EK051810 Exp. 5/4/2019
  • EK281808 Exp. 5/27/2019
  • EL101810 Exp. 6/8/2019
  • EL141807 Exp. 6/12/2019
  • EA081910 Exp. 7/7/2019
  • EA161908 Exp. 7/15/2019
  • EA301908 Exp. 7/29/2019
  • EB111907 Exp. 8/10/2019
  • EC041907 Exp. 8/31/2019

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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