Drug recall
INDOMETHACIN Capsules, 25 MG, 60 capsule plastic bottles, RX ONLY, Packaged BY DIRECT DISPENSING INC MIAMI FL…
FDA recall event 27354 · Class II · Direct Dispensing, Inc.
Key facts
| Event ID | 27354 |
|---|---|
| Recall numbers | D-036-4 |
| Recalling firm | Direct Dispensing, Inc. |
| Product type | Drugs |
| Products | INDOMETHACIN Capsules, 25 MG, 60 capsule plastic bottles, RX ONLY, Packaged BY DIRECT DISPENSING INC MIAMI FL 38147, MFG BY MYLAN PHARAMCEUTICALS, MORGANTOWN, WV. , NDC 57866-3981- 2 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Label Mix-up: bottles labeled as containing 25 mg strength capsules actually contain 50 mg capsules |
| Initiation date | Sep 23, 2003 |
| City | Miami |
| Country | United States |
| FEI number | 1052154 |
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