D-0100-2023 Class II Terminated
FDA drug recall D-0100-2023 was initiated by Lupin Pharmaceuticals Inc. on Dec 12, 2022 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study. The recall status is terminated (terminated Jan 31, 2024). Affected quantity: 16,056 30 count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 18, 2023
- Initiation Date
- Dec 12, 2022
- Termination Date
- Jan 31, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,056 30 count bottles
Product Description
Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06
Reason for Recall
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot # A200171, Exp 12/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0100-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026