Drug recall D-0648-2024
Product
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.
Lots and codes
Lot #: F201517, Exp 11/30/2024
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 4554 bottles
- Distribution
- USA nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 21, 2024
- Terminated
- April 29, 2025
Related products
- Cefixime – drug information
- NDC 68180-423 Cefixime · Cefixime 400 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-405 Cefixime · Cefixime 100 mg/5mL · Lupin Pharmaceuticals, Inc.
- NDC 68180-407 Cefixime · Cefixime 200 mg/5mL · Lupin Pharmaceuticals, Inc.