D-0641-2024Class I

Aurobindo Pharma USA Inc

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2024-08-28

Distribution

NJ, NY & PA

Firm state

Product quantity

240 bottles

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

Reason for recall

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

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.

Code / lot info

Lot#: AC2523005A, Exp 6/30/2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.