Rifampin Capsules Recalled Due to Manufacturing Control Deviation
Lupin Pharmaceuticals is recalling Rifampin 150 mg capsules (lot #A200170) nationwide due to a Current Good Manufacturing Practice deviation with an out-of-specification impurity detected during manufacturing.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a manufacturing quality control deviation with no reported illnesses or injuries. The out-of-specification impurity was detected through routine testing, making this a precautionary recall.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Rifampin Capsules, USP, 150 mg (lot #A200170, expiration December 2023) distributed nationwide. The recall involves 7,872 bottles of 30-count HDPE bottles (NDC 68180-658-06).
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation discovered during manufacturing. Testing identified an out-of-specification result for 1-Methyl-4-Nitroso Piperazine (MNP), an impurity that exceeded acceptable limits.
Rifampin is a prescription antibiotic used to treat tuberculosis and other serious infections. Patients currently taking this medication should consult their healthcare provider before making any changes. Those with a bottle from lot #A200170 should contact their pharmacy or healthcare provider for guidance on the recalled medication.
The recalled product
- Product
- RIFAMPIN (RIFAMPIN)
- Brand
- RIFAMPIN
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antibiotic / Prescription
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 #A200170
- exp. date December 2023
Distribution
Distributed nationwide across the United States.
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