Akorn Recalls RIFAMPIN FOR INJECTION Due to Impurity Specifications
Akorn, Inc. is recalling 6,861 vials of RIFAMPIN FOR INJECTION USP, 600 mg because a known impurity failed to meet specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Akorn, Inc. is recalling 6,861 vials of RIFAMPIN FOR INJECTION USP, 600 mg (NDC: 17478-151-42). The recall affects Lot # 14RIF1(A) with an expiration date of 9/30/2016. The product was distributed nationwide in the United States.
The recall was initiated because the product failed impurity/degradation specifications, specifically obtaining an out-of-specifications result for a known impurity. The U.S. Food and Drug Administration has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
Healthcare providers and patients should stop using the affected lot of RIFAMPIN FOR INJECTION USP and contact their pharmacist or the manufacturer for further instructions.
The recalled product
- Product
- RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 6,861
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 (2)
- Lot #: 14RIF1(A)
- Expiry: 9/30/2016.
Distribution
Distributed nationwide across the United States.
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