Recalling firm
Lupin Pharmaceuticals Inc.
Product type
Drug
Status
Terminated
Report date
2024-06-05
Distribution
USA Nationwide
Firm state
MD
Product quantity
51,006 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
Defective container: lack of seal integrity.
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
Code / lot info
Lot #F305184, F305185, F305186, Exp 7/31/ 2025
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.