The Recall Desk
SevereFDA (Drugs)·D-1215-2019·Announced 2019-05-01

CMC Enterprise Pharmacy Recalls Magnesium Sulfate Bags Due to Sterility Concerns

CMC Enterprise Pharmacy is recalling 3,007 bags of Magnesium Sulfate 4 GM in NS 50 mL due to a lack of sterility assurance. The affected lots 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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility assurance in an injectable drug) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.

Plain-English summary

CMC Enterprise Pharmacy is recalling 3,007 bags of Magnesium Sulfate 4 GM in NS 50 mL. The recall was initiated because of a lack of sterility assurance in 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 12, 2019, to September 21, 2019. The distribution pattern for these products is limited to North Carolina. The source text does not report any specific illnesses or injuries associated with this recall.

Healthcare facilities and consumers in North Carolina should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the pharmacy or disposed of according to local regulations. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Magnesium Sulfate 4 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
Hazard
Affected units
3,007

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 (10)

  • Lots: EK131812 Exp. 5/12/2019
  • EL051809 Exp. 6/3/2019
  • EL111808 Exp. 6/9/2019
  • EL141808 Exp. 6/12/2019
  • EA031909 Exp. 7/2/2019
  • EA141909 Exp. 7/13/2019
  • EA311910 Exp. 7/30/2019
  • EB061909 Exp. 8/5/2019
  • EC121909 Exp. 9/8/2019
  • EC251910 Exp. 9/21/2019

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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