Recall: D-1343-2022

Class II - Potentially Harmful

Class IIClassification

2022-07-28Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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

CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.

Distribution

Product was distributed nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.