Rifampin Antibiotic Capsules Recalled for Subpotency and Failed Specifications
Lupin Pharmaceuticals recalls Rifampin 300mg capsules (lot A200817, exp 1/2024) due to subpotency and failed impurities/degradation specifications. Patients should consult their doctor before stopping medication.
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: FDA Class II recall of a subpotent antibiotic with failed quality specifications. No illnesses or injuries have been reported. The hazard presents a risk of treatment failure, but without reported injury, this qualifies as a risk-of-harm product with no actual harm yet confirmed.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Rifampin Capsules USP 300mg in 30-count bottles. The recalled lot is identified by code A200817 with an expiration date of 1/2024.
The product has been found to be subpotent, containing less active ingredient than specified, and has failed impurities and degradation testing specifications. These defects could prevent the medication from working as intended to treat infections.
The recalled product was distributed to 32 wholesale and distributor accounts, which further distributed to 156 distribution sites. Approximately 165,600 bottles of the affected lot were involved in this recall.
Patients who have this product should not discontinue their medication without first consulting their healthcare provider. Healthcare providers and patients with this lot should contact Lupin Pharmaceuticals for recall instructions and guidance.
The recalled product
- Product
- RIFAMPIN (RIFAMPIN)
- Brand
- RIFAMPIN
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antibiotic
- Hazard
- subpotency
- 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 (1)
- A200817 exp 1/2024
Distribution
Distribution scope not specified by the agency.
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