Drug recall
Assured Pain Relief for Arthritis, (Acetaminophen 650mg), 24 Caplets (NDC 45738-717-24), Distributed by…
FDA recall event 60622 · Class II · Aphena Pharma Solutions LLC
Key facts
| Event ID | 60622 |
|---|---|
| Recall numbers | D-1211-2012 |
| Recalling firm | Aphena Pharma Solutions LLC |
| Product type | Drugs |
| Products | Assured Pain Relief for Arthritis, (Acetaminophen 650mg), 24 Caplets (NDC 45738-717-24 ), Distributed by: Greenbrier International, Inc. Chesapeake, VA 23320 Consumer's Choice Pain Relief for… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Marketed without an approved NDA/ANDA: The recall is due to incorrect dosage information indicated on the primary bottle and the outside carton labeling. The labeling contained the following… |
| Initiation date | Dec 2, 2011 |
| Termination date | Jun 11, 2013 |
| City | Glasgow |
| State | KY |
| Country | United States |
| FEI number | 3008685379 |
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