Rifampin Capsules Recalled for Exceeding Impurity Specification Limits
Akorn, Inc. is recalling 18,145 bottles of Rifampin Capsules, USP 150 mg due to impurity levels exceeding the FDA's 5 ppm interim specification limit for 1-Methyl-4-Nitrosopiperazine (MNP).
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with impurity levels exceeding specifications and no reported illnesses or injuries. This represents a risk-of-harm pharmaceutical product where injury has not yet been reported, meeting the Score 3 (High) criteria.
Plain-English summary
Akorn, Inc. is recalling Rifampin Capsules, USP, 150 mg in 30-count bottles (NDC 61748-015-30) distributed nationwide and in Puerto Rico. The recall involves three specific lots: 3192818 (expires 10/31/2022), 3199700 (expires 03/31/2023), and 3203853 (expires 02/29/2024), representing 18,145 bottles.
The recall was initiated because the finished product exceeds the FDA interim specification limit of 5 ppm for 1-Methyl-4-Nitrosopiperazine (MNP), an impurity. The affected lots failed to meet required impurity and degradation specifications.
Patients taking Rifampin from the recalled lots should contact their healthcare provider or pharmacist for advice. Healthcare providers and pharmacists should stop dispensing the affected lots immediately and quarantine remaining stock.
The recalled product
- Product
- Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
- Manufacturer
- Akorn, Inc.
- Category
- Drug
- Hazard
- chemical-impurity
- degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot#: 3192818
- Exp 10/31/2022
- 3199700
- Exp 03/31/2023
- 3203853
- Exp 02/29/2024
Distribution
Distributed nationwide across the United States.
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