D-0485-2019 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 20, 2019
- Initiation Date
- October 26, 2018
- Termination Date
- April 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2770 bags; 277 selling units
Product Description
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
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).
Distribution Pattern
Nationwide
Code Information
ABD807, exp 05/2020