Home / Recalls / Allegiant Health / D-0500-2017

D-0500-2017 Class II Terminated

Recalled by Allegiant Health — Deer Park, NY

FDA drug recall D-0500-2017 was initiated by Allegiant Health on Feb 16, 2017 and is designated Class II. Reason for recall: cGMP deviations - presence of rubber particles found loose in the bulk product. The recall status is terminated (terminated Jun 29, 2018). Affected quantity: 70,176 bottles; 9,000,000 tablets (bulk).

Recall details

Product Type: Drugs
Report Date: Mar 8, 2017
Initiation Date: Feb 16, 2017
Termination Date: Jun 29, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 70,176 bottles; 9,000,000 tablets (bulk)

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.

Distribution pattern

Nationwide

Code information

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0500-2017
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.