Recalls / Class I
Class ID-0641-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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.
- Brand name
- Acetaminophen Aspirin And Caffeine
- Generic name
- Acetaminophen, Aspirin And Caffeine
- Active ingredients
- Acetaminophen, Aspirin, Caffeine
- Route
- Oral
- NDC
- 58602-882
- FDA application
- ANDA211695
- Affected lot / code info
- Lot#: AC2523005A, Exp 6/30/2025
Why it was recalled
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc
- Manufacturer
- Aurohealth LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 240 bottles
- Distribution pattern
- NJ, NY & PA
Timeline
- Recall initiated
- 2024-07-11
- FDA classified
- 2024-08-20
- Posted by FDA
- 2024-08-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0641-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.