Drug recall D-1252-2020
Product
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01
Reason for recall
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Lots and codes
Lot #: F800779, Expiry 4/2020
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 4,518 bottles
- Distribution
- Nationwide with the United States and Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 15, 2020
- Terminated
- June 7, 2021
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.