Prescription Rifampin Capsules Recalled Due to Failed Quality Specifications
Amerisource Health Services is recalling Rifampin Capsules USP 300 mg nationwide due to failed impurities and degradation specifications. Affected patients should contact their healthcare provider before using remaining inventory.
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 drug recall where the product failed impurities and degradation quality specifications. No illnesses or injuries have been reported, but the failed quality standards represent a risk-of-harm product where injury has not yet been reported, qualifying it as High severity per the rubric.
Plain-English summary
Amerisource Health Services LLC is recalling Rifampin Capsules USP 300 mg (100 capsules per carton) distributed nationwide. The affected product is identified by lot number 1007805 with an expiration date of December 31, 2023.
The recall was initiated because this lot failed to meet impurities and degradation specifications during quality control testing. This indicates the product does not meet pharmaceutical standards for chemical purity and stability.
A total of 3,091 cartons have been distributed nationwide. Patients with prescriptions for this lot should contact their healthcare provider or pharmacist before using any remaining inventory. Healthcare providers should advise patients not to use this lot without medical guidance.
The recalled product
- Product
- RIFAMPIN (RIFAMPIN)
- Brand
- RIFAMPIN
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Prescription Antibiotic
- Hazard
- impurity-failure
- product-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 (2)
- Lot #: 1007805
- exp. 12/31/2023
Distribution
Distributed nationwide across the United States.
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