FDA Recall D-0641-2024

Aurobindo Pharma USA Inc · East Windsor, NJ

Class I — life-threatening Ongoing 672 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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.

Lot / code: Lot#: AC2523005A, Exp 6/30/2025

Quantity: 240 bottles

Reason for recall

Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.

Recall record

Recall number: D-0641-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: NJ, NY & PA
Recall initiated: 2024-07-11
Classified by FDA Center: 2024-08-20
FDA published: 2024-08-28
Recalling firm: Aurobindo Pharma USA Inc
Firm location: East Windsor, NJ

Drug identification

Brand name(s): ACETAMINOPHEN ASPIRIN AND CAFFEINE
Generic name(s): ACETAMINOPHEN, ASPIRIN AND CAFFEINE
Manufacturer(s): Aurohealth LLC
NDC(s): 58602-882
Route(s): ORAL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls