FDA Recalls（７月８日）
公開日時 2009/07/24 04:00
| FDA Recalls |
8-Jul-09 |
| CLASS I |
| Dextroamphetamine Sulfate Tablets; Isosorbide Mononitrate Extended-Release Tablets; Morphine Sulfate Extended-Release Tablets; Morphine Sulfate Immediate-Release Oral Tablets; Propafenone HCl Tablets |
| 1) USP, CII, 10 mg, packaged in 100 tablet bottles, 12 bottles/case, Rx only, NDC 58177-312-04; 2) 30 mg, packaged in 100 tablet bottles, 12/case, Rx only, NDC 58177-222-04; 3) 60 mg, packaged in 100 and 500 tablet bottles, 12/case, Rx only, NDC 58177-238-04 (100 tab), and NDC 58177-238-08 (500 tab); 4) CII, 15 mg, packaged in 100 tablet bottles, 12/case, Rx only, NDC 58177-310-04; 5) CII, 15 mg, packaged in 100 tablet bottles, Rx only, NDC 58177-313-04; 6) CII, 30 mg, packaged in 100 tablet bottles, Rx only, NDC 58177-314-04; 7) 150 mg, packaged in 100 tablet bottles (NDC 58177-331-04), and 10 x 10 unit dose packs (NDC 58177-331-11), all packed 12/case, Rx only; 8) 225 mg, packaged in 100 tablet bottles, 12/case, Rx only, NDC 58177-332-04; 9) 300 mg, packaged in 100 tablet bottles, 12/case, Rx only, NDC 58177-333-04. |
| Manufacturer: |
KV Pharmaceutical Co., Saint Louis, MO. |
| Recalled by: |
Ethex Corporation, Bridgeton, MO, by press release and letters on Nov. 7, 2008, by letters on Nov. 10 and Nov. 19, 2008. Firm-initiated recall is ongoing. |
| Distribution: |
Nationwide; 5,694.360 bottles (The volume is a total of all products recalled by Ethex in this Enforcement Report). |
| Reason: |
The products may contain oversized tablets. |
| Recall numbers: |
D-1241/1249-2009. |
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