D-0648-2024 Class II Terminated
FDA drug recall D-0648-2024 was initiated by Lupin Pharmaceuticals Inc. on Aug 21, 2024 and is designated Class II. Reason for recall: Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study. The recall status is terminated (terminated Apr 29, 2025). Affected quantity: 4554 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 4, 2024
- Initiation Date
- Aug 21, 2024
- Termination Date
- Apr 29, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4554 bottles
Product Description
Cefixime for Oral Suspension USP, 100 mg/5 mL, 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
Reason for Recall
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Distribution Pattern
USA nationwide.
Code Information
Lot #: F201517, Exp 11/30/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0648-2024
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026