Class I
Terminated
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
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- October 26, 2018
- Posted
- February 20, 2019
- Recall Number
- D-0485-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2770 bags; 277 selling units
- Firm Location
- Princeton, NJ, United States
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
Nationwide
Lot / Code Info
ABD807, exp 05/2020
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