FDAClass IIOctober 29, 2014

Assured Aspirin Enteric Safety Coated Tablets recall: Subpotent

Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320 UPC 639277018328.

Why was Assured Aspirin Enteric Safety Coated Tablets recalled?

Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.

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#12084; Exp. 05/16

Product
Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320 UPC 639277018328.
Recalling firm
American Family Pharmacy, LLC
Quantity
4,207,200 tablets
Distribution
VA, WA, and CA.
Recall date
October 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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