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Overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate andDextroamphetamine Sulfate can have serious or life-threatening consequences.In the case of Propafenone HCl, these consequences can include arrhythmias(irregular heartbeat) and low blood pressure. In the case of IsosorbideMononitrate, these consequences can include fainting and low blood pressure.In the case of Morphine Sulfate, these consequences can include respiratorydepression (difficulty or lack of breathing) and low blood pressure. In thecase of Dextroamphetamine Sulfate, these consequences can include rapid heartrate and high blood pressure.
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The lots involved in the recall were all shipped prior to May 22, 2008 andare as follows:
Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240,81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates rangingfrom 3/2009 to 3/2011
Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to2/2011
Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246, 89092,89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to3/2011
Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355,66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009
Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466,66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009
Morphine Sulfate Extended Release Tablets, 15 mg: Lots: 81175, 82514-16,89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from12/2008 to 2/2010
Morphine Sulfate Immediate Release Tablets, 15 mg: Lots: 77852-54, 81746,82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to1/2011
Morphine Sulfate Immediate Release Tablets, 30 mg: Lots: 75093, 77855-57,82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from8/2009 to 3/2011
Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934, 75892, 77945,81137, 86320 with expiration dates ranging from 6/2009 to 5/2011
The 150 mg Propafenone Hydrochloride Tablets is a white, scored round filmcoated tablet with "ETH" on one side and "331" with a bisect on the reverse.The 225 mg Propafenone Hydrochloride Tablets is a white, scored round filmcoated tablet with "ETH" on one side and "332" with a bisect on the reverse.The 300 mg Propafenone Hydrochloride Tablets is a white, scored round filmcoated tablet with "ETH" on one side and "333" with a bisect on the reverse.
The 30 mg Isosorbide Mononitrate Extended Release Tablet is an oval,reddish-pink, film-coated tablet with a debossed "E" bisecting "30" on oneside and bisect on the other side. The 60 mg Isosorbide Mononitrate ExtendedRelease Tablet is an oval, yellow film-coated tablet with a debossed "E"bisect "60" on one side and bisect on the other side.
The 15 mg Morphine Sulfate Extended Release Tablet is a green oval tabletwith "15" on one side and an "E" on the reverse. The 15 mg Morphine SulfateImmediate Release Tablet is a round brown tablet with a "15" on one side andan "ETH" on the reverse. The 30 mg Morphine Sulfate Immediate Release Tabletis a capsule shaped brown tablet with "30" on one side and an "ETHEX" on thereverse.
The 10 mg Dextroamphetamine Sulfate Tablet is a round, flat-face, beveledge, orange mottled tablet debossed "ETHEX" and "312" on one side and double-scored on the other side.
ETHEX Corporation has initiated recall notifications to wholesalers andretailers who have received any inventory of the recalled product lots withinstructions for returning the recalled products. The notification alsoincludes instructions for the retailers/pharmacies to contact consumers whowere dispensed these drugs for replacement of the product and/or refund. Ifthe wholesalers and retailers have not already done so, they are urged tocontact the number below regarding procedures for returning the recalledproducts. If consumers have any questions about the recall, they should callthe number listed below for customer inquiries, their physician, theirpharmacist or other health care provider.
Consumers who experience any adverse reactions to these drugs shouldcontact their physician and/or healthcare provider immediately.
Any customer inquiries related to this action should be addressed to ETHEXCustomer Service at 1-800-748-1472, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: [email protected] withrepresentatives available Monday through Friday, 8:00 am to 5:00 pm CentralStandard Time (CST).
This recall is being conducted with the knowledge of the U.S. Food andDrug Administration (FDA).
Any adverse reactions experienced with the use of these products, and/orquality problems may also be reported to the FDA's MedWatch Program by phoneat 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website atwww.fda.gov/medwatch.
Safe Harbor
ETHEX Corporation is a wholly-owned subsidiary of KV PharmaceuticalCompany, which we refer to as "KV" or the "Company". The information in thisrelease may contain various forward-looking statements within the meaning ofthe United States Private Securities Litigation Reform Act of 1995 ("PSLRA")and which may be based on or include assumptions concerning KV's operations,future results and prospects. Such statements may be identified by the use ofwords like "plans", "expect", "aim", "believe", "projects", "anticipates","commit", "intend", "estimate", "will", "should", "could" and otherexpressions that indicate future events and trends.
All forward-looking statements are based on current expectations and aresubject to risk and uncertainties. In connection with the "safe harbor"provisions, KV provides the following cautionary statements identifyingimportant economic, competitive, political and technology factors, which amongothers, could cause actual results or events to differ materially from thoseset forth or implied by the forward-looking statements and relatedassumptions.
Such factors include (but are not limited to) the following: (1) changesin the current and future business environment, including interest rates andcapital and consumer spending; (2) the difficulty of predicting FDA approvals,including timing, and that any period of exclusivity may not be realized; (3)acceptance and demand for new pharmaceutical products; (4) the impact ofcompetitive products and pricing, including as a result of so-calledauthorized-generic drugs; (5) new product development and launch, includingthe possibility that any product launch may be delayed or that productacceptance may be less than anticipated; (6) reliance on key strategicalliances; (7) the availability of raw materials and/or products manufacturedfor the Company under contract manufacturing arrangements with third parties;(8) the regulatory environment, including regulatory agency and judicialactions and changes in applicable law or regulations; (9) fluctuations inrevenues; (10) the difficulty of predicting international regulatory approval,including timing; (11) the difficulty of predicting the pattern of inventorymovements by the Company's customers; (12) the impact of competitive responseto the Company's sales, marketing and strategic efforts, including theintroduction or potential introduction of generic or competing productsagainst products sold by the Company and its subsidiaries; (13) risks that theCompany may not ultimately prevail in litigation, including challenges to ourintellectual property rights by actual or potential competitors or to ourability to market generic products due to brand company patents and challengesto other companies' introduction or potential introduction of generic orcompeting products by third parties against products sold by the Company orits subsidiaries including without limitation the litigation and claimsreferred to in Note 16 of the Notes to Consolidated Financial Statements inthe Company's Form 10-Q for the quarter ended June 30, 2008; (14) actions bythe Internal Revenue Service with respect to the Company's stock option grantsand accounting practices; (15) the possibility that KV's current estimates ofthe financial effect of certain product recalls, including the recall of thelots of Propafenone HCl tablets, Isosorbide ER tablets, Morphine Sulfate ERtablets, Morphine Sulfate IR tablets and Dextroamphetamine Sulfate tabletsdescribed above, could prove to be incorrect; (16) whether any productrecalls, including the recall of the lots of Propafenone HCl tablets,Isosorbide ER tablets, Morphine Sulfate ER tablets, Morphine Sulfate IRtablets and Dextroamphetamine Sulfate tablets described above, result inlitigation, agency action or material damages; (17) the possibility that thefindings of the Audit Committee inquiry referenced in the Company's Form 10-Qfor the quarter ended June 30, 2008, could have a material impact on theCompany's financial results; (18) new product selection, development andlaunch; and (19) the risks detailed from time to time in the Company's filingswith the Securities and Exchange Commission.
This discussion is by no means exhaustive, but is designed to highlightimportant factors that may impact the Company's outlook. We are under noobligation to update nay of the forward-looking statements after the date ofthis release.
SOURCE ETHEX Corporation
