Patients receiving high doses of levetiracetam by rapid intravenous infusion for the treatment of status epilepticus would be most at risk for severe adverse events. Dr. Reddy’s has not received any reports of adverse events related to this recall.
Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) and Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg/100 mL (5mg/mL) are both indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible:
-Partial onset seizures
- Myoclonic seizures in patients with juvenile myoclonic epilepsy
- Primary generalized tonic-clonic seizures
Each product is packaged in single-dose infusion bags with an aluminum overwrap, 10 single-dose bags packed in a carton.
The batch was distributed nationwide between November 4, 2024, and November 6, 2024, to wholesalers.
DESCRIPTION OF MISLABELLED BAGS BEING RECALLED: | NDC Number | Product Overwrap Description | Product Infusion Bag Primary Description | Lot Number | Expiration Date |
| 43598-635-52 | Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL | Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag. | A1540076 | 08/2026 |
| 43598-636-52 | Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL | Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL single-dose bag | A1540076 | 08/2026 |
DESCRIPTION OF CARTON BEING RECALLED:
| NDC Number | Carton Description | Lot Number | Expiration Date |
| 43598-636-10 | Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL 10 Single-Dose Bags | A1540076 | 08/2026 |
"Dr. Reddy’s Laboratories, Inc is notifying its distributors and customers to arrange for return of any recalled product. Wholesalers, distributors, hospitals, and pharmacies with an existing inventory of the lot being recalled, should stop use and distribution and quarantine the product immediately for return/replacement of all recalled products. Wholesalers, distributors, and pharmacies that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them," the company added.
"For instructions on returning product or additional assistance, call Inmar at 1-877-645-1584 between the hours of 9 a.m. to 5 p.m. ET, Monday through Friday. Consumers with questions regarding this recall can contact Dr. Reddy’s Medical Information Call Center at 1-888-375-3784 (1-888-DRL-DRUG) between the hours of 8 a.m. to 8 p.m. ET, Monday through Friday. Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product. This recall is being executed with the knowledge of the U.S. Food and Drug Administration," Dr Reddys stated.
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