Levetiracetam in 0.54 % Sodium Chloride Injection 1 recall: Labeling Error
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…
Why was Levetiracetam in 0.54 % Sodium Chloride Injection 1 recalled?
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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
ABD807, exp 05/2020
- Product
- 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…
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Quantity
- 2770 bags; 277 selling units
- Distribution
- Nationwide
- Recall date
- February 20, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)