FDA-Drug2017-03-08Class II

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

Allegiant Health
Hazard

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

Sold states
Nationwide
Affected count
70,176 bottles; 9,000,000 tablets (bulk)
Manufactured in
75 N Industry Ct, N/A, Deer Park, NY, United States
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: Allegiant Health Deer Park, NY 11729

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0500-2017

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