FDA Recall D-0485-2019

Dr. Reddy's Laboratories, Inc. · Princeton, NJ

Class I — life-threatening Terminated 1621 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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: Gland Pharma Limited Hyderabad - 500 043, India Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 UPC 343598637525 ---- NDC 43598-637-52

Lot / code: ABD807, exp 05/2020

Quantity: 2770 bags; 277 selling units

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).

Recall record

Recall number: D-0485-2019
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2018-10-26
Classified by FDA Center: 2019-02-11
FDA published: 2019-02-20
Terminated: 2023-04-04
Recalling firm: Dr. Reddy's Laboratories, Inc.
Firm location: Princeton, NJ

Drug identification

Brand name(s): LEVETIRACETAM
Generic name(s): LEVETIRACETAM INJECTION
Manufacturer(s): Dr.Reddy's Laboratories Inc
NDC(s): 43598-635, 43598-636, 43598-637
Route(s): INTRAVENOUS

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