Drug recall
Tramadol Hydrochloride Tablets, 50 mg, NDC 0172-6515-60, NDC 0172-6515-70 and NDC 0172-6515-10 (100s, 500s and…
FDA recall event 32146 · Class II · Able Laboratories, Inc.
Key facts
| Event ID | 32146 |
|---|---|
| Recall numbers | D-336-5 |
| Recalling firm | Able Laboratories, Inc. |
| Product type | Drugs |
| Products | Tramadol Hydrochloride Tablets, 50 mg, NDC 0172-6515-60, NDC 0172-6515-70 and NDC 0172-6515-10 (100s, 500s and 100 count unit dose tablets), Manufactured for: IVAX Pharmaceuticals, Inc., Miami, FL… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a lack of assurance that testing conducted for release and stability conformed to standard operating procedures. |
| Initiation date | May 25, 2005 |
| City | Cranbury |
| Country | United States |
| FEI number | 3004106764 |
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