February 2024 FDA Recall Drug by Amerisource Health Services Llc
D-0320-2024 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Amerisource Health Services Llc on February 1, 2024 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0320-2024
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
02-01-2024
02-14-2024
2,850 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11
Batch or Lot Expiration Information
Lot# : 1012275, Exp 02/28/2025
