Rifampin Capsules USP
Subpotent Drug
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Cause type: Nitrosamine impurity
Trace nitrosamine impurities such as NDMA, NDEA or NMBA found above the acceptable daily limit. Nitrosamines are probable human carcinogens that can form during manufacturing or storage. This is the cause behind the large valsartan, losartan and ranitidine (Zantac) recalls. All nitrosamine impurity recalls.
Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031.
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.
Subpotent Drug
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.
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.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Free recall alerts
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.