Class II · Moderate risk
Rifampin Capsules USP
Subpotent Drug
Rifampin for Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.
Affected NDC
67457-0445-60
Compare with the code on your package — it is the most precise check available.
Drug: Rifampin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Rifampin NDC 67457-0445 |
600 mg/10mL | Injection, Powder, Lyophilized, for Solution Intravenous |
Mylan Institutional LLC | Rx |
- Recalling firm
- Mylan Laboratories Limited (Sterile Products Division)
- NDC code
- 67457-445-60
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0139-2020 · FDA notice
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.
Other Rifampin recalls
See all
Class II · Moderate risk
Rifampin Capsules USP
Failed Impurities/Degradation Specification.
Class II · Moderate risk
Rifampin Capsules USP 300mg
Subpotent Drug and Failed Impurities/Degradation Specifications
Class II · Moderate risk
Rifampin Capsules USP 150mg
Subpotent Drug and Failed Impurities/Degradation Specifications
Class II · Moderate risk
Rifampin Capsules USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other impurity / degradation recalls from 2019
All impurity / degradation recalls
Class II · Moderate risk
Sumatriptan Succinate Tablets
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class II · Moderate risk
Sumatriptan Succinate Tablets
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class III · Low risk
Bimatoprost Ophthalmic Solution
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Free recall alerts
Know the day your medication is recalled
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.