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Drug FDA Class I Ongoing Mislabeling

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.

Aurobindo Pharma USA Inc Published Aug 28, 2024

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 75/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Aurobindo Pharma USA Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Affected products (1)

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.

ACETAMINOPHEN ASPIRIN AND CAFFEINE · 240 bottles

NDC: 58602-882, 58602-882-21, 58602-882-38
Code info: Lot#: AC2523005A, Exp 6/30/2025

Affected areas

New JerseyNew YorkPennsylvania

Timeline

  1. Initiated
    Jul 11, 2024
  2. Published
    Aug 28, 2024
Recall number
D-0641-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.