Drug recall
Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs…
FDA recall event 77576 · Class II · Time-Cap Laboratories, Inc.
Key facts
| Event ID | 77576 |
|---|---|
| Recall numbers | D-1055-2017 |
| Recalling firm | Time-Cap Laboratories, Inc. |
| Product type | Drugs |
| Products | Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg. |
| Initiation date | Jun 16, 2017 |
| Report date | Aug 9, 2017 |
| Termination date | May 29, 2020 |
| 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 · Source date: