Patients who manage the wrong labeled products can experience side effects according to the risk statement issued by the company.
BECAUSE THE IS LABELLED as 500 mg/100 mL But Actualy Contains 1,000 mg/100 mL dose, The Patient Coul Levetiracetam THICH COULD LEAD Lead to Immediate and Serious Side Effects Including HyperSensitivity Reactions, Liver Injury, Hematological Toxicity, somnolence, fatigue, dizzine, coordination difficulties, agitation, aggression, depressed level of consciousness, respiratory depression and coma.
Patients with high doses of rebecirasatam due to fast venous injection for state epilepsy treatment will be the most dangerous for serious side effects. Dr. S ‘S’ did not receive a report on the side effects related to this recall.
0.75% sodium chloride injection, 1,000 mg/100 ml (10 mg/ml) and 0.82% sodium chloride injection, 500 mg/100 ml (5 mg/ml) Rebecirasetam, Rebecirasetam was found in adult adjunct therapy (≥16).
-Plation seizure
-Fires attack of adolescent myopia epilepsy
-The first generalized tonic attack
Each product is packaged in a single dose injection bag packaged in an aluminum excess type and 10 single capacity bags in the box. Identification information such as a lot number, expiration date and NDC is shown in the table below. The deployment was distributed nationwide nationwide between November 4, 2024 and November 6, 2024.
Recall the description of a misunderstanding bag | |||
NDC number | Product excess lapping description | Product injection bag 1st description | Lot number |
43598-635-52 | 0.75% Sodium chloride injection 1,000 mg/100 mL Rebecirasetam | 0.82% sodium chloride injection 500 mg/100 ml in a single capacity bag in Rebecirasetam. | A1540076 |
43598-636-52 | 0.75% Sodium chloride injection 1,000 mg/100 mL Rebecirasetam | 0.75% Sodium chloride injection 1,000 mg/100 ml single capacity bag of Revecirasetam | A1540076 |
Description of the recalled box | |||
NDC number | Box explanation | Lot number | Expiration date |
43598-636-10 | 0.75% Sodium chloride injection 1,000 mg/100 ml 10 single capacity of Rebecirasetam | A1540076 | 08/2026 |
“Dr. Reddy’s Laboratories, INC is notified to arrange the return of the recalled products to distributors and customers. Through the existing inventory of the recalled rod, it is necessary to replace the replaced products for distribution and distribution of wholesalers, distributors, hospitals and pharmacies. It may have been received.
This recall is being executed with knowledge of the US Food Pharmacy.