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.
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 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.
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