Magnesium sulfate pouch recalled as Class I for containing tranexamic acid
One lot of Magnesium Sulfate in Water for Injection is being recalled after a foil pouch labeled as magnesium sulfate was found to contain an IV bag of tranexamic acid.
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 rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.
Plain-English summary
Magnesium Sulfate in Water for Injection is being recalled. About 784 cartons of 12 x 100 mL were distributed nationwide in the United States.
The recall was initiated for a product mix up: a foil pouch labelled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of tranexamic acid instead. The FDA has classified this recall as Class I, its most serious category.
Affected product is lot AH250162 with an expiry date of 8/31/2027.
Clinicians and pharmacies can identify affected product by the lot number and expiry date above, and may contact the recalling firm for further information.
The recalled product
- Product
- MAGNESIUM SULFATE (MAGNESIUM SULFATE IN WATER FOR)
- Brand
- MAGNESIUM SULFATE
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Category
- Drug — Injectable
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 (2)
- Lot: AH250162
- Exp 8/31/2027
Distribution
Distributed nationwide across the United States.
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