Drug Enforcement D-0496-2024

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Status

Terminated

Classification

Class II

Report Date

May 22, 2024

Termination Date

April 29, 2025

Product Information

Product description
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04
Product quantity
17,070 bottles
Reason for recall
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
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-0496-2024
Event ID
94492
Recall initiation date
April 24, 2024
Center classification date
May 14, 2024
Code info
Lot # F305442, Exp 8/30/2025
More code info
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