D-0284-2024 Class II Terminated
FDA drug recall D-0284-2024 was initiated by Lupin Pharmaceuticals Inc. on Jan 5, 2024 and is designated Class II. Reason for recall: Subpotent Drug and Failed Impurities/Degradation Specifications The recall status is terminated (terminated Aug 27, 2024). Affected quantity: 165,60 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 7, 2024
- Initiation Date
- Jan 5, 2024
- Termination Date
- Aug 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 165,60 bottles
Product Description
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06
Reason for Recall
Subpotent Drug and Failed Impurities/Degradation Specifications
Distribution Pattern
Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
Code Information
A200817 exp 1/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0284-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026