Drug recall
Acetaminophen 500 mg Tablets, OTC, distributed in bottles of 100 tablets and 1000 tablets or in bulk form…
FDA recall event 35422 · Class II · PDK Labs, Inc
Key facts
| Event ID | 35422 |
|---|---|
| Recall numbers | D-259-6 |
| Recalling firm | PDK Labs, Inc |
| Product type | Drugs |
| Products | Acetaminophen 500 mg Tablets, OTC, distributed in bottles of 100 tablets and 1000 tablets or in bulk form. Manufactured by PDK Labs, Inc., Hauppauge, NY 11788. The product was distributed under the… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Firm received a complaint of spotted (discolored) tablets due to mold contamination |
| Initiation date | May 10, 2006 |
| Termination date | Apr 29, 2008 |
| City | Hauppauge |
| State | NY |
| Country | United States |
| FEI number | 2432932 |
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