Amneal magnesium sulfate IV bags recalled for tranexamic acid mix-up
Some cartons of Amneal Magnesium Sulfate IV bags were mislabeled and contained Tranexamic Acid (a different medication) instead. This mix-up affects lot AH250162 with an expiration date of 8/31/2027. The error was discovered before the product reached patients.
From the FDA notice · Read the official notice ↗ · All Amneal Pharmaceuticals recalls
What to do
- Do not use IV bags from lot AH250162 (exp. 8/31/2027).
- Verify the medication inside matches the label before administering.
- Contact your pharmacy or hospital if you have this lot in stock.
- Report any use of the wrong medication to FDA MedWatch immediately.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 784 (12x100mL) cartons
- Illnesses reported
- None reported
- Manufactured in
- 400 Crossing Blvd Fl 3, Bridgewater, NJ, United States
- Classification
- Class I
- Recall number
- D-0478-2026
In the FDA's words
- Description
- Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3. Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead. Lot: AH250162, Exp 8/31/2027 Distribution: U.S.A. Nationwide Affected quantity: 784 (12x100mL) cartons
- Hazard
- Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
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