The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1547-2022·Announced 2022-10-05

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).

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units
18,145

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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