FDA Drug Class II — Moderate

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

Hazard

cGMP deviations - presence of rubber particles found loose in the bulk product.

Products

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: Allegian
Brand
Allegiant Health
UPC
Lot # 6K28817, Exp 10/19 (Packaged in bottle), 10/17 (Bulk)

Units Affected

70,176 bottles; 9,000,000 tablets (bulk)