HealthA2Z CHEWABLE Aspirin 81 mg recalled over manufacturing violations

Recall date

February 16, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Allegiant Health recalls HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code…

Recall number

D-0500-2017

FDA classification

Class II

Brand / firm

Allegiant Health

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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