FDA recall D-1343-2022

Lupin Pharmaceuticals Inc. · Class II · drug

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.

Distribution

Product was distributed nationwide.

Key facts

Status
Terminated
Initiation date
2022-07-28
Report date
2022-08-24
Termination date
2023-10-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1343-2022