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

FDA recall notice · announced March 8, 2017 · Allegiant Health

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide
Lot/code information: Lot # 6K28817, Exp 10/19 (Packaged in bottle), 10/17 (Bulk)
Quantity: 70,176 bottles; 9,000,000 tablets (bulk)
Status: Terminated
Products in this recall event:
- 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 (D-0500-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.