Drug recall D-1343-2022

Class II Terminated reported Aug 24, 2022

Product

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.

Lots and codes

Lot #A200170, exp. date December 2023

Recall details

Recalling firm
Lupin Pharmaceuticals Inc., Baltimore, MD
Quantity
7,872/30 count bottles
Distribution
Product was distributed nationwide.
Type
Voluntary: Firm initiated
Recall initiated
July 28, 2022
Terminated
October 5, 2023

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