Acetaminophen Aspirin And Caffeine Tablet, Film Coated
FDA Recall NDC 58602-882
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Acetaminophen Aspirin And Caffeine (NDC 58602-882). A significant event, classified as Class I, was initiated on Jul 11, 2024 by Aurohealth Llc. The reported reason for this action was: "Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Jul 11, 2024
Aug 28, 2024
240 bottles
Recall Profile & Regulatory Data
Event ID
94966
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Aurobindo Pharma USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NJ, NY & PA
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.
Batch or Lot Expiration Information
Lot# : AC2523005A, Exp 6/30/2025
Affected Packages Involved in this Recall
58602-882-21Product
58602-882-38Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
