D-1252-2020 Class II Terminated
FDA drug recall D-1252-2020 was initiated by Lupin Pharmaceuticals Inc. on April 15, 2020 and is designated Class II. Reason for recall: Subpotent Drug: low out of specification (OOS) test result observed in long term stability study. The recall status is terminated (terminated June 7, 2021). Affected quantity: 4,518 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 29, 2020
- Initiation Date
- April 15, 2020
- Termination Date
- June 7, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,518 bottles
Product Description
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.
Distribution Pattern
Nationwide with the United States and Puerto Rico.
Code Information
Lot #: F800779, Expiry 4/2020