D-0496-2024 Class II Terminated
FDA drug recall D-0496-2024 was initiated by Lupin Pharmaceuticals Inc. on Apr 24, 2024 and is designated Class II. Reason for recall: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. The recall status is terminated (terminated Apr 29, 2025). Affected quantity: 17,070 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 22, 2024
- Initiation Date
- Apr 24, 2024
- Termination Date
- Apr 29, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,070 bottles
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
Reason for Recall
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Distribution Pattern
USA nationwide
Code Information
Lot # F305442, Exp 8/30/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0496-2024
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026