FDA recall D-0500-2017

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-02-16

Report date

2017-03-08

Termination date

2018-06-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deer Park, NY, United States

Primary source

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