D-0641-2024 Class I Ongoing
FDA drug recall D-0641-2024 was initiated by Aurobindo Pharma USA Inc on July 11, 2024 and is designated Class I. Reason for recall: Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information. The recall status is ongoing. Affected quantity: 240 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 28, 2024
- Initiation Date
- July 11, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 240 bottles
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.
Reason for Recall
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Distribution Pattern
NJ, NY & PA
Code Information
Lot#: AC2523005A, Exp 6/30/2025