The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1216-2019·Announced 2019-05-01

Magnesium Sulfate IV Bags Recalled Due to Lack of Sterility Assurance

CMC Enterprise Pharmacy is recalling 196 bags of Magnesium Sulfate 6 GM in NS 50 mL due to a lack of sterility assurance. The product was 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 rubric, an FDA Class II recall involving a significant hazard like lack of sterility assurance in an IV product corresponds to a severity score of 4 (Severe), as it carries a risk of significant injury or infection.

Plain-English summary

CMC Enterprise Pharmacy is recalling 196 bags of Magnesium Sulfate 6 GM in NS 50 mL. The recall is being conducted because of a lack of sterility assurance in the product. The affected lots are EA111909 (Exp. 7/10/2019), EB061910 (Exp. 8/5/2019), and EB131909 (Exp. 8/12/2019).

The product was manufactured by Enterprise Pharmacy in Charlotte, North Carolina, and was distributed within North Carolina. The FDA has classified this recall as Class II, which means there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and consumers should stop using the affected product and contact the recalling firm for further instructions or a replacement.

The recalled product

Product
Magnesium Sulfate 6 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
196

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 (3)

  • Lots: EA111909 Exp. 7/10/2019
  • EB061910 Exp. 8/5/2019
  • EB131909 Exp. 8/12/2019

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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