FDA DrugsClass I
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further pa...
Published: April 8, 2026Recall ID: D-0478-2026Category: drugsCountry: US
Reason for Recall / 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.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Bridgewater |
| State | NJ |
| Openfda › Unii | SK47B8698T |
| Openfda › Route | INTRAVENOUS |
| Openfda › Rxcui › 1 | 1658259 |
| Openfda › Rxcui › 2 | 1658262 |
| Openfda › Spl id | 8ec55093-e97e-4389-b992-36a61608bf5a |
| Openfda › Brand name | MAGNESIUM SULFATE |
| Openfda › Spl set id | 29241655-49c9-4bc4-89f2-79a0b24b562e |
| Openfda › Package ndc › 1 | 70121-1719-9 |
| Openfda › Package ndc › 2 | 70121-1719-2 |
| Openfda › Package ndc › 3 | 70121-1720-9 |
| Openfda › Package ndc › 4 | 70121-1720-3 |
| Openfda › Product ndc › 1 | 70121-1719 |
| Openfda › Product ndc › 2 | 70121-1720 |
| Openfda › Generic name | MAGNESIUM SULFATE IN WATER FOR |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | MAGNESIUM SULFATE HEPTAHYDRATE |
| Openfda › Manufacturer name | Amneal Pharmaceuticals LLC |
| Openfda › Application number | ANDA216597 |
| Openfda › Is original packager | true |
| Event id | 98587 |
| Address 1 | 400 Crossing Blvd Fl 3 |
| Code info | Lot: AH250162, Exp 8/31/2027 |
| Postal code | 08807-2863 |
| Report date | 20260408 |
| Product type | Drugs |
| Product quantity | 784 (12x100mL) cartons |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260318 |
| Initial firm notification | Letter |
| Center classification date | 20260413 |
Overview
- Recalling FirmAmneal Pharmaceuticals, LLC
- StatusOngoing
- Risk LevelClass I
- DistributionU.S.A. Nationwide