Recall Enforment Report D-0039-2024

Drug Recall Enforcement Report Class III voluntary initiated by Amerisource Health Services LLC, originally initiated on 09-01-2023 for the product HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11 The product was recalled due to failed impurities/degradation specifications: out of specification results in the repackaged product for impurities at the 12-month time point.. The product was distributed nationwide and the recall is currently terminated.

Field Name	Field Value
Event ID	93089 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0039-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11
Reason For Recall	Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	3,344 cartons Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	10-11-2023
Recall Initiation Date	09-01-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	07-16-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Amerisource Health Services LLC
Code Info	Lot#: 1007002, Exp 12/31/2023 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	68084-447-11; 68084-447-01
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products