Why it was recalled
cGMP deviations - presence of rubber particles found loose in the bulk product.
Product description
HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code 369168288362 (FP0545)], b) bulk product (6K28817), OTC, Manufactured by: Allegiant Health Deer Park, NY 11729
Lot numbers, UPCs & expiration codes
Lot # 6K28817, Exp 10/19 (Packaged in bottle), 10/17 (Bulk)
Where it was sold
Nationwide
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-0500-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 16, 2017
- FDA report date
- Mar 8, 2017
- Quantity
- 70,176 bottles; 9,000,000 tablets (bulk)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Allegiant Health
Original FDA data
Every field from FDA enforcement report D-0500-2017, exactly as published.
Show all FDA fields
- City
- Deer Park
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 76495
- Address
- 75 N Industry Ct
- Code information
- Lot # 6K28817, Exp 10/19 (Packaged in bottle), 10/17 (Bulk)
- Postal code
- 11729-4601
- Report date
- Mar 8, 2017
- Product type
- Drugs
- Recall number
- D-0500-2017
- Classification
- Class II
- Recalling firm
- Allegiant Health
- Product quantity
- 70,176 bottles; 9,000,000 tablets (bulk)
- Termination date
- Jun 29, 2018
- Reason for recall
- cGMP deviations - presence of rubber particles found loose in the bulk product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code 369168288362 (FP0545)], b) bulk product (6K28817), OTC, Manufactured by: Allegiant Health Deer Park, NY 11729
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 16, 2017
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Feb 28, 2017