Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceut...
FDA Recall #D-1343-2022 — Class II — July 28, 2022
Product Description
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
Reason for Recall
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
7,872/30 count bottles
Distribution
Product was distributed nationwide.
Code Information
Lot #A200170, exp. date December 2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated