Drug recall
Pseudoephedrine HCl 100 mg/Chlorpheniramine Maleate 12 mg Capsules, 100 Capsules, NDC 10914-950-01, Rx only…
FDA recall event 49025 · Class III · Time-Cap Labs
Key facts
| Event ID | 49025 |
|---|---|
| Recall numbers | D-045-2009 |
| Recalling firm | Time-Cap Labs |
| Product type | Drugs |
| Products | Pseudoephedrine HCl 100 mg/Chlorpheniramine Maleate 12 mg Capsules, 100 Capsules, NDC 10914-950-01, Rx only, BRIGHTON PHARMACEUTICALS label --- Manufactured for: Brighton Pharmaceuticals, Inc. Cary… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: the lots were labeled with an incorrect expiration date (1 year longer). |
| Initiation date | Jul 9, 2008 |
| Termination date | Jun 26, 2012 |
| City | Farmingdale |
| State | NY |
| Country | United States |
| FEI number | 2431898 |
At a glance
- 1–9 Products in this recall
- 10–99 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