Rifampin Capsules Recalled Due to Failed Quality Specifications
RemedyRepack Inc. is recalling Rifampin Capsules, 300 mg, due to failed impurities and degradation specifications. The affected product was distributed to a single pharmacy account in Pennsylvania.
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: This is an FDA Class II recall for failed pharmaceutical quality specifications (impurities and degradation). No illnesses or injuries have been reported. The recall meets the criteria for High severity as a risk-of-harm pharmaceutical product where injury has not yet been reported.
Plain-English summary
RemedyRepack Inc. is recalling Rifampin Capsules, 300 mg, distributed under repackaged National Drug Code (NDC) 70518-2404-00. The product was originally manufactured by Lupin Pharma, Baltimore, MD. The recall affects two specific lots: J0599794-022322 (expiring 02/28/2023) and J0621369-052622 (expiring 06/30/2023), totaling 132 blister cards (3,960 capsules).
The product is being recalled due to failed impurities and degradation specifications. RemedyRepack Inc. determined that the product did not meet the required quality standards established by the FDA.
The affected product was distributed to one pharmacy account in Pennsylvania. Patients whose prescriptions were filled with this product should verify the lot number and NDC code to determine if they received affected capsules.
Patients with affected prescriptions should contact their pharmacy or healthcare provider. Do not discontinue Rifampin without consulting a healthcare professional. Anyone with questions about this recall can contact RemedyRepack Inc. for further information.
The recalled product
- Product
- Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Prescription Antibiotic
- Hazard
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 (4)
- Lot #: J0599794-022322
- exp. date 02/28/2023
- J0621369-052622
- exp. date 06/30/2023
Distribution
Distributed in 1 state:
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