Drug recall
Isosorbide Mononitrate Extended-Release Tablets, 30 mg, 100 Bags of One Tablet Each, Rx only, Mfg by: KV…
FDA recall event 52442 · Class II · American Health Packaging
Key facts
| Event ID | 52442 |
|---|---|
| Recall numbers | D-1885-2009, D-1886-2009 |
| Recalling firm | American Health Packaging |
| Product type | Drugs |
| Products | Isosorbide Mononitrate Extended-Release Tablets, 30 mg, 100 Bags of One Tablet Each, Rx only, Mfg by: KV Pharmaceutical Co.; Mfg for: ETHEX Corporation, St. Louis, MO 63044; Pkg by: American Health…, Potassium Chloride Extended-release Capsules, USP, 10 mEq (750 mg), 100 Bags of One Capsule Each, Rx only, Mfg by: KV Pharmaceuticals Co.; Mfg for: Ethex Corporation, St. Louis, MO 63044; Pkg by… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The products were not manufactured in conformance with cGMP's, The products were not manufactured in conformance with cGMP's. |
| Initiation date | Feb 2, 2009 |
| Termination date | Jul 11, 2011 |
| City | Columbus |
| State | OH |
| Country | United States |
| FEI number | 3000209995 |
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