D-0500-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2017
- Initiation Date
- February 16, 2017
- Termination Date
- June 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70,176 bottles; 9,000,000 tablets (bulk)
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
Reason for Recall
cGMP deviations - presence of rubber particles found loose in the bulk product.
Distribution Pattern
Nationwide
Code Information
Lot # 6K28817, Exp 10/19 (Packaged in bottle), 10/17 (Bulk)