Aurobindo Pharma USA Inc: Drug Recall

Recall #D-0641-2024 · 07/11/2024

Class I: Dangerous

Recall Details

Recall Number: D-0641-2024
Classification: Class I
Product Type: Drug
Recalling Firm: Aurobindo Pharma USA Inc
Status: Ongoing
Date Initiated: 07/11/2024
Location: East Windsor, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 240 bottles

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.

Distribution Pattern

NJ, NY & PA

Other Recalls by Aurobindo Pharma USA Inc

Class II: Risk 05/22/2025

cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class II: Risk 12/06/2024

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Class II: Risk 11/07/2024

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II: Risk 11/07/2024

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II: Risk 11/07/2024

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

View all recalls by Aurobindo Pharma USA Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.