Recalls / Class I

Class ID-0485-2019

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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

Brand name: Levetiracetam
Generic name: Levetiracetam Injection
Active ingredient: Levetiracetam
Route: Intravenous
NDCs: 43598-635, 43598-636, 43598-637
FDA application: ANDA206880
Affected lot / code info: ABD807, exp 05/2020

Why it was 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).

Recalling firm

Firm: Dr. Reddy's Laboratories, Inc.
Manufacturer: Dr.Reddy's Laboratories Inc
Notification channel: Letter
Type: Voluntary: Firm initiated
Address: 107 College Rd E, N/A, Princeton, New Jersey 08540-6623

Distribution

Quantity: 2770 bags; 277 selling units
Distribution pattern: Nationwide

Timeline

Recall initiated: 2018-10-26
FDA classified: 2019-02-11
Posted by FDA: 2019-02-20
Terminated: 2023-04-04
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0485-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.