FDA recall D-0040-2015

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.

Reason for recall

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

Distribution

VA, WA, and CA.

Key facts

Status

Terminated

Initiation date

2014-09-15

Report date

2014-10-29

Termination date

2015-09-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0040-2015