← FDA ENFORCEMENT
D-0496-2024Class II

Lupin Pharmaceuticals Inc.

Recalling firm
Lupin Pharmaceuticals Inc.
Product type
Drug
Status
Terminated
Report date
2024-05-22
Distribution
USA nationwide
Firm state
MD
Product quantity
17,070 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

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

Code / lot info

Lot # F305442, Exp 8/30/2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.