Akorn Rifampin Capsules Recalled for Impurity Specification Failure
Akorn is recalling Rifampin Capsules USP 300 mg (30-, 60-, and 100-count bottles) distributed nationwide because finished product exceeds the interim limit for 1-Methyl-4-Nitrosopiperazine impurity. The recall affects approximately 177,439 bottles.
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: This is an FDA Class II recall involving failed impurity specifications without reported hospitalizations or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported merit a High severity score.
Plain-English summary
Akorn, Inc. is recalling Rifampin Capsules, USP, 300 mg, in 30-count, 60-count, and 100-count bottles, distributed nationwide and in Puerto Rico. Approximately 177,439 bottles are affected.
The finished product in certain lots exceeds the interim limit of 5 ppm for 1-Methyl-4-Nitrosopiperazine (MNP). The impurity specification failure was detected through quality control testing.
Patients with affected batches should consult their healthcare provider or pharmacist. A complete list of affected lot numbers and expiration dates is available from the FDA.
The recalled product
- Product
- 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.
- Manufacturer
- Akorn, Inc.
- Category
- Drug
- Hazard
- 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 (20)
- Lot#: a) 3192827
- Exp 10/31/2022
- 3196136
- Exp 12/31/2022
- 3202198
- Exp 07/31/2023
- 3203658
- 3209114
- Exp 11/30/2023
- 3203851
- Exp 02/29/2024
- b) 3191254
- Exp 09/30/2022
- 3192820
- 3192822
- 3192824
- 3192825
- 3196141
- Exp 01/31/2023
- 3196143
Distribution
Distributed nationwide across the United States.
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