Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL Infusion bag, Manufactured by: Gland Pharma Limited Hyderabad - 500 043, India Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 UPC 343598637525 ---- NDC 43598-637-52
Drug Recall
Official source record
- Recall number
- D-0485-2019
- Event ID
- 81441
- Classification
- Class I
- Status
- Terminated
- Recalling company
- Dr. Reddy's Laboratories, Inc.
- Reason for recall
- 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).
- Report date
- February 20, 2019
- Recall initiation date
- October 26, 2018
- Termination date
- April 4, 2023
- Distribution pattern
- Nationwide
Drug product identifiers
- Manufacturer
- Dr.Reddy's Laboratories Inc
- Brand name
- LEVETIRACETAM
- Generic name
- LEVETIRACETAM INJECTION
- Substance name
- LEVETIRACETAM
- Product NDCs
- 43598-635; 43598-636; 43598-637
- Package NDCs
- 3435986375; 43598-635-10; 43598-635-52; 43598-636-10; 43598-636-52; 43598-637-10; 43598-637-52
- Route
- INTRAVENOUS
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class I mean?
A situation in which there is a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death.
Is this recall still active?
According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.
Where can I find more official information?
The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.
