July 2024 FDA Recall Acetaminophen Aspirin And Caffeine by Aurobindo Pharma Usa Inc
D-0641-2024 - Labeling
This Class I drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc on July 11, 2024 for the product Acetaminophen Aspirin And Caffeine. The FDA reported the reason for recall as labeling. The product was distributed in NJ, NY & PA and the recall is currently ongoing.
Recall Number: D-0641-2024
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
07-11-2024
08-28-2024
240 bottles
Recall Profile & Regulatory Data
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.
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.
Aurobindo Pharma USA Inc
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.
NJ, NY & PA
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
Batch or Lot Expiration Information
Lot# : AC2523005A, Exp 6/30/2025
