Status
Terminated
Drug Enforcement D-0274-2024
Failed Impurities/Degradation Specifications
Classification
Class II
Report Date
February 7, 2024
Termination Date
December 27, 2024
Product Information
- Product description
- Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
- Product quantity
- 4,608 Bottles
- Reason for recall
- Failed Impurities/Degradation Specifications
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
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-0274-2024
- Event ID
- 93730
- Recall initiation date
- January 3, 2024
- Center classification date
- January 26, 2024
- Code info
- Lot #: F304833, Exp 06/2025
- More code info
- —