PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 8, 2017 Initiated: February 16, 2017 #D-0500-2017

Product Description

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.

Details

Recalling Firm
Allegiant Health
Units Affected
70,176 bottles; 9,000,000 tablets (bulk)
Distribution
Nationwide
Location
Deer Park, NY

Frequently Asked Questions

What product 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. Recalled by Allegiant Health. Units affected: 70,176 bottles; 9,000,000 tablets (bulk).
Why was this product recalled?
cGMP deviations - presence of rubber particles found loose in the bulk product.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 8, 2017. Severity: Moderate. Recall number: D-0500-2017.