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.
What this means for you
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
- Hazard
- cgmp-deviation
- pharmaceutical-impurity
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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