Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Gland Pharma Limited | Hyderabad, India | Makes it and tests it | Problems found, fixed voluntarilyJul 25, 2024 · 7 inspections |
Recalls
- Mar 13, 2025 · Class I · Dr. Reddy's Laboratories, Inc.
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Lots: Lot: A1540076, Exp 08/31/2026 - Oct 26, 2018 · Class I · Dr. Reddy's Laboratories, Inc.
Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).
Lots: ABD807, exp 05/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Levetiracetam: every company that makes it
- Form
- injection, intravenous
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA206880
- On the market since
- Jun 8, 2018
- Package NDCs
43598-635-1043598-635-52- Official label
- DailyMed (National Library of Medicine), updated Dec 31, 2021
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?