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
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FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
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Frequently asked questions
What does a Class I mean?
FDA classifies this recall as Class I. See how to read an FDA recall record for what each classification level means.
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.
Official guidance and record verification
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How to interpret this historical record
This record is preserved as published by FDA, as of April 4, 2023.
Status as reported: Terminated.
This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.
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