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All forward looking statements are based on current expectations and are subject to risk and uncertainties. In connection with the "safe harbor" provisions, KV provides the following cautionary statements identifying important economic, competitive, political and technology factors, which among others, could cause actual results or events to differ materially from those set forth or implied by the forward looking statements and related assumptions.
The 30 mg Isosorbide Mononitrate Extended Release Tablet is an oval, reddish pink, film coated tablet with a debossed "E" bisecting "30" on one side and bisect on the other side. The 60 mg Isosorbide Mononitrate Extended Release Tablet is an oval, yellow film coated tablet with a debossed "E" bisect "60" on one side and bisect on the other side.
300 mg: Lots: 72834, 76016 18, 81246, 89092, 89732, 90530, 90532, and 91641 42 with expiration dates ranging from 6/2009 to 3/2011
Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009
The 15 mg Morphine Sulfate Extended Release Tablet is a green oval tablet with "15" on one side and an "E" on the reverse. The 15 mg Morphine Sulfate Immediate Release Tablet is a round brown tablet with a "15" on one side and an "ETH" on the reverse. The 30 mg Morphine Sulfate Immediate Release Tablet is a capsule shaped brown tablet with "30" on one side and an "ETHEX" on the reverse.
ST. LOUIS, Nov. 7 /PRNewswire/ ETHEX Corporation announced today that it has voluntarily recalled to the consumer level specific lots of five generic /non branded products that it markets. These lots have been recalled as a precaution, due to the possibility that they may contain oversized Louis Vuitton Galliera Date Code
Morphine Sulfate Immediate Release Tablets, 30 mg: Lots: 75093, 77855 57, 82297, 82521 22, 87239, 88925, and 90288 98 with expiration dates ranging from 8/2009 to 3/2011
This discussion is by no means exhaustive, but is designed to highlight important factors that may impact the Company's outlook. We are under no obligation to update nay of the forward looking statements after the date of this release.
The 150 mg Propafenone Hydrochloride Tablets is a white, scored round film coated 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 film coated 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 film coated tablet with "ETH" Louis Vuitton Turenne on one side and "333" with a bisect on the reverse.
The 10 mg Dextroamphetamine Sulfate Tablet is a round, flat face, bevel edge, orange mottled tablet debossed "ETHEX" and "312" on one side and double scored on the other side.
Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011
ETHEX Corporation Initiated Nationwide Voluntary Recalls of Specific Lots of Five Generic Products Due to the Potential for Oversized Tablets
Consumers who experience any adverse reactions to these drugs should contact their physician and/or healthcare provider immediately. Food and Drug Administration (FDA).
Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011
ETHEX Corporation has initiated recall notifications to wholesalers and retailers who have received any inventory of the recalled product lots with instructions for returning the recalled products. The notification also includes instructions for the retailers/pharmacies to contact consumers who were dispensed these drugs for replacement of the product and/or refund. If the wholesalers and retailers have not already done so, they are urged to contact the number below regarding procedures for returning the recalled products. If consumers have any questions about the recall, they should call the number listed below for customer inquiries, their physician, their pharmacist or other health care provider.
Propafenone HCl Tablets, Lv Messenger Pm Voyager
Morphine Sulfate Immediate Release Tablets, 15 mg: Lots: 77852 54, 81746, 82519 20, 84113, and 90276 78 with expiration dates ranging from 9/2009 to 1/2011
Isosorbide Mononitrate Extended Release Lv Limited Edition
Morphine Sulfate Extended Release Tablets, 15 mg: Lots: 81175, 82514 16, 89660, 89664, 89667, 90249 51, and 91687 with expiration dates ranging from 12/2008 to 2/2010
Overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and Dextroamphetamine 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 Isosorbide Mononitrate, these consequences can include fainting and low blood pressure. In the case of Morphine Sulfate, these consequences can include respiratory depression (difficulty or lack of breathing) and low blood pressure. In the case of Dextroamphetamine Sulfate, these consequences can include rapid heart rate and high blood pressure.
Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014 15, 81243 45, 89731, 90527 29, and 90657 with expiration dates ranging from 3/2009 to 2/2011
ETHEX Corporation is a wholly owned subsidiary of KV Pharmaceutical Company, which we refer to as "KV" or the "Company". The information in this release may contain various forward looking statements within the meaning of the 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 of words like "plans", "expect", "aim", "believe", "projects", "anticipates", "commit", "intend", "estimate", "will", "should", "could" and other expressions that indicate future events and trends.
Tablets, 60 mg: Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009
tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs.
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