FDA recall D-0641-2024

Aurobindo Pharma USA Inc · Class I · 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.

Reason for recall

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

Distribution

NJ, NY & PA

Key facts

Status
Ongoing
Initiation date
2024-07-11
Report date
2024-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0641-2024