Drug Enforcement D-0641-2024

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

Status

Ongoing

Classification

Class I

Report Date

August 28, 2024

Termination Date

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Product 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.
Product quantity
240 bottles
Reason for recall
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
NJ, NY & PA

Location & Firm

Recalling firm
Aurobindo Pharma USA Inc
Address
279 Princeton Hightstown Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0641-2024
Event ID
94966
Recall initiation date
July 11, 2024
Center classification date
August 20, 2024
Code info
Lot#: AC2523005A, Exp 6/30/2025
More code info
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