Drug Enforcement D-0518-2024

Defective container: lack of seal integrity.

Status

Terminated

Classification

Class II

Report Date

June 5, 2024

Termination Date

April 29, 2025

Product Information

Product description
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04
Product quantity
51,006 bottles
Reason for recall
Defective container: lack of seal integrity.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
Lupin Pharmaceuticals Inc.
Address
Harborplace Tower, 111 S Calvert St Fl 21st

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0518-2024
Event ID
94602
Recall initiation date
May 8, 2024
Center classification date
May 29, 2024
Code info
Lot #F305184, F305185, F305186, Exp 7/31/ 2025
More code info
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