Class II · Moderate risk
Rifampin Capsules USP
Subpotent Drug
Rifampin for Injection USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
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. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
Affected NDC
17478-0151-42
Compare with the code on your package — it is the most precise check available.
Drug: Rifampin
- Recalling firm
- Akorn, Inc.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0231-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 recalls by Akorn, Inc.
All 2015 recalls
Class II · Moderate risk
Tropicamide Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Ropivacaine Hydrochloride Injection USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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