Recall Enforment Report D-0641-2024

Drug Recall Enforcement Report Class I voluntary initiated by Aurobindo Pharma USA Inc, originally initiated on 07-11-2024 for the product Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-882-21. The product was recalled due to labeling: missing label - some bottles are missing the the manufacturers label that includes the drug facts information.. The product was distributed in Nj, Ny & Pa and the recall is currently ongoing.

Field Name	Field Value
Event ID	94966 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0641-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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	NJ, NY & PA 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	Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-882-21.
Reason For Recall	Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	240 bottles 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	08-28-2024
Recall Initiation Date	07-11-2024 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Aurobindo Pharma USA Inc
Code Info	Lot#: AC2523005A, Exp 6/30/2025 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	58602-882-21; 58602-882-38
Status	Ongoing

Recalled Products