Drug recall
Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC…
FDA recall event 83414 · Class II · Macleods Pharma Usa Inc
Key facts
| Event ID | 83414 |
|---|---|
| Recall numbers | D-1844-2019 |
| Recalling firm | Macleods Pharma Usa Inc |
| Product type | Drugs |
| Products | Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15) and c) 1000 count (NDC 33342-159-44) bottles, Manufactured : Macleods Pharma USA… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specifications |
| Initiation date | Jul 17, 2019 |
| Report date | Aug 21, 2019 |
| Termination date | Feb 9, 2021 |
| City | Plainsboro |
| State | NJ |
| Country | United States |
| FEI number | 3009750394 |
At a glance
- 1–9 Products in this recall
- None 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: