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Recall Observatory FDA recall evidence

Drug 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.

D-0641-2024

July 11, 2024

Class I

Product summary

Firm
Aurobindo Pharma USA Inc
Event
Event 94966
Status
Ongoing
Classification
Class I
Quantity
240 bottles
Official record key
drug-enforcement:D-0641-2024

Official wording

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

Code information: Lot#: AC2523005A, Exp 6/30/2025

Distribution pattern: NJ, NY & PA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Missing Label - some bottles are missing