Drug recall
Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count…
FDA recall event 69248 · Class II · American Family Pharmacy, LLC
Key facts
| Event ID | 69248 |
|---|---|
| Recall numbers | D-0040-2015 |
| Recalling firm | American Family Pharmacy, LLC |
| Product type | Drugs |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution. |
| Initiation date | Sep 15, 2014 |
| Report date | Oct 29, 2014 |
| Termination date | Sep 25, 2015 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 3004971302 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: