Drug recall D-0500-2017

Class II Terminated reported Mar 8, 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.

Lots and codes

Lot # 6K28817, Exp 10/19 (Packaged in bottle), 10/17 (Bulk)

Recall details

Recalling firm
Allegiant Health, Deer Park, NY
Quantity
70,176 bottles; 9,000,000 tablets (bulk)
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
February 16, 2017
Terminated
June 29, 2018