December 2022 FDA Recall Rifampin by Amerisource Health Services Llc
D-0165-2023 - Failed Impurities/Degradations Specifications

This Class II drug recall was voluntarily initiated by Amerisource Health Services Llc on December 20, 2022 for the product Rifampin. The FDA reported the reason for recall as failed impurities/degradations specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0165-2023

Reason for Recall
Failed Impurities/Degradations Specifications
Initiated
12-20-2022
Reported
01-25-2023
Quantity
3,091 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91416
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Amerisource Health Services LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-06-2024
Product Description About Product Description
Full technical description of the product.
Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-586-01 (Individual Dose NDC: 60687-586-11)

Batch or Lot Expiration Information

Lot# : 1007805, exp. 12/31/2023

Affected Packages Involved in this Recall

60687-586-11 Rifampin
60687-586-01 Rifampin
60687-575-11 Rifampin
60687-575-21 Rifampin