Why it was recalled
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.
Lot numbers, UPCs & expiration codes
Lot#: AC2523005A, Exp 6/30/2025
Where it was sold
NJ, NY & PA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0641-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jul 11, 2024
- FDA report date
- Aug 28, 2024
- Quantity
- 240 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc
Original FDA data
Every field from FDA enforcement report D-0641-2024, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94966
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot#: AC2523005A, Exp 6/30/2025
- Postal code
- 08520-1401
- Report date
- Aug 28, 2024
- Product type
- Drugs
- Recall number
- D-0641-2024
- Classification
- Class I
- Recalling firm
- Aurobindo Pharma USA Inc
- Product quantity
- 240 bottles
- Reason for recall
- Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Jul 11, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 20, 2024