FDAClass IIMarch 8, 2017

HealthA2Z CHEWABLE Aspirin recall: CGMP Deviations

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

Why was HealthA2Z CHEWABLE Aspirin recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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
Recalling firm
Allegiant Health
Quantity
70,176 bottles; 9,000,000 tablets (bulk)
Distribution
Nationwide
Recall date
March 8, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls