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
Reported: January 18, 2023 Initiated: December 12, 2022 #D-0100-2023
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.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 16,056 30 count bottles
- Distribution
- Distributed Nationwide in the USA
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 16,056 30 count bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 18, 2023. Severity: Moderate. Recall number: D-0100-2023.
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