Rifampin Capsules USP
Failed Impurities/Degradation Specification.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Subpotent Drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06
Compare with the code on your package — it is the most precise check available.
Drug: Rifampin
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Failed Impurities/Degradation Specification.
Subpotent Drug and Failed Impurities/Degradation Specifications
Subpotent Drug and Failed Impurities/Degradation Specifications
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Failed content uniformity specifications.
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Presence of Foreign Substance
Presence of particulate matter: a white thread-like structure in the cartridge
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