Recalls / Class II

Class IID-1548-2022

Product

Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031.

Affected lot / code info

Lot#: a) 3192827, Exp 10/31/2022; 3196136, Exp 12/31/2022; 3202198, Exp 07/31/2023; 3203658, Exp 07/31/2023; 3209114, Exp 11/30/2023; 3203851, Exp 02/29/2024; b) 3191254, Exp 09/30/2022; 3192820, Exp 09/30/2022; 3192822, Exp 10/31/2022; 3192824, Exp 10/31/2022; 3192825, Exp 10/31/2022; 3196141, Exp 01/31/2023; 3196143, Exp 02/28/2023; 3203870, Exp 11/30/2023; 3203871, Exp 02/29/2024; c) 3190636, Exp 09/30/2022; 3192813, Exp 09/30/2022; 3196132, Exp 12/31/2022; 3196133, Exp 12/31/2022; 3196138, Exp 01/31/2023; 3199702, Exp 03/31/2023; 3199703, Exp 03/31/2023

Why it was recalled

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

Recalling firm

Firm

Akorn, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

5605 Centerpoint Ct Ste A, N/A, Gurnee, Illinois 60031-5278

Distribution

Quantity

177,439 bottles

Distribution pattern

USA Nationwide and Puerto Rico

Timeline

Recall initiated

2022-09-21

FDA classified

2022-09-28

Posted by FDA

2022-10-05

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-1548-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.