Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals,...

FDA Recall #D-0283-2024 — Class II — January 5, 2024

Recall #D-0283-2024 Date: January 5, 2024 Classification: Class II Status: Terminated

Product Description

Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06

Reason for Recall

Subpotent Drug and Failed Impurities/Degradation Specifications

Recalling Firm

Lupin Pharmaceuticals Inc. — Baltimore, MD

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

15,576 Bottles

Distribution

Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.

Code Information

A200816 exp 1/2024 A201248 exp 3/2024

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated