FDA Recalls（５月６日）
公開日時 2009/05/14 04:00
| FDA Recalls |
6-May-09 |
| CLASS III |
| Chromagen Caplet; Chromagen FA Caplet; Chromagen Forte Caplet; Encora Capsule/Tablet; Niferex Gold Tablet; Niferex 150 Forte Capsule; PreCare Chewable Tablet; PreCare Premier Tablet; PreCare Conceive Tablet; PremesisRx Tablet; PrimaCare Capsule/Tablet; PrimaCare Advantage Capsule/Tablet; PrimaCare ONE Capsule; PrimaCare ONE Capsule; Repliva 21/7 Tablet |
| (a) Rx, an oral iron supplement packaged in 90 caplet bottles. MNDC 64011-198-26; (b) Rx. an oral iron supplement packaged in 90 caplet bottles. NDC 64011-199-26; (c) Rx, an oral iron supplement packaged in 90 caplet bottles, NDC 64011-197-26; (d) each carton contains 30 capsules and 30 tablets packaged in individual blisters, NDC 64011-166-36, Rx; (e) iron supplement, Rx. packaged in 90 tablet bottles. NDC 64011-162-26; (f) Rx, packaged in 90 capsule bottles. NDC 64011-164-26; (g) packaged in 30 tablet bottles, Rx. NDC 64011-024-19; (h) packaged in 30 caplet bottles, Rx. NDC 64011-195-19; (i) packaged in 30 tablet bottles, Rx. NDC 64011-014-19; (j) packaged in 30 tablet bottles, Rx. NDC 64011-019-19; (k) each carton contains 30 capsules and 30 tablets packaged in individual blisters, Rx. NDC 64011-204-28; (l) each carton contains 30 capsules and 30 tablets packaged in individual blisters, NDC 64011-230-28, Rx; (m) packaged in 30 capsule bottles, Rx. NDC 64011-200-19; (n) packaged in 30 capsule bottles, Rx. NDC 6401-218-19; (o) packaged in 28 day tablet pack (21 active, 7 absorption period tablets) Rx. NDC 64011-0207-34. |
| Manufacturer: |
KV Pharmaceutical Co., Saint Louis, MO. |
| Recalled by: |
Ther-Rx Corp., Bridgeton, MO, By press release and letter on Jan. 28, 2009 and additional press release and letter dated Feb. 3, 2009. Firm-initiated recall is ongoing. |
| Distribution: |
Nationwide and countries of Indonesia, Singapore, Switzerland, Hungary, Canada, Brazil, Australia; unknown number units were distributed. |
| Reason: |
The products were not manufactured in conformance with GMPs. |
| Recall numbers: |
D-242/256-2009. |
| EDITORS' NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III - violative product not likely to cause adverse health consequences. Editors of "The Pink Sheet" appreciate hearing from any company that would like to provide additional information on any recall listed in a weekly tabulation. |
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