From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 19 May 2008 08:05:06 -0500 (CDT)
Subject: Medicis Announces Voluntary Recall of Solodyn (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up (May 16)
Medicis Announces Voluntary Recall of Solodyn (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up (May 16)
Mon, 19 May 2008 08:01:00 -0500
Medicis announced that the company is voluntarily recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of the antibiotic SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg, 30-count bottles (NDC 99207-461-30). Medicis has received a report that one bottle in lot number B080037 contains AZASAN (azathioprine tablets) 75 mg (NDC 65649-231-51) instead of SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg.
Updates: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 19 May 2008 15:44:18 -0500 (CDT)
Subject: CDER New 5/19/2008
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May 19, 2008
- New and Generic Drug Approvals
- ATACAND HCT (candesartan cilexetil and hydrochlorothiazide) Tablets, AstraZeneca LP, Formulation Revision
- Geodon (ziprasidone hydrochloride) Capsules, Pfizer, Inc., Labeling Revision
- Geodon (ziprasidone mesylate) Injection, Pfizer, Inc., Labeling Revision
- Granisetron Hydrochloride Injection, Wockhardt USA, Inc., Tentative Approval
- Hydrochlorothiazide Capsules, Apotex Corp., Approval
- Invega (paliperidone) Extended-Release Tablets, Janssen LP, Labeling Revision
- Keppra (levetiracetam) Injection, UCB, Inc., New or Modified Indication
- LEVITRA (vardenafil hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
- Metoprolol Succinate Extended-Release Tablets, KV Pharmaceutical Co., Approval
- Mitoxantrone Hydrochloride Injection, Dabur Oncology, Plc., Approval
- Mycobutin (rifabutin) Capsules, Pharmacia and Upjohn Co., Labeling Revision
- Nevirapine Tablets, Matrix Laboratories, Ltd., Tentative Approval
- Topiramate Capsules, Cobalt Laboratories, Inc., Tentative Approval
Updates: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 19 May 2008 16:04:15 -0500 (CDT)
Subject: FDA News Digest for May 19, 2008
FDA News Digest
May 19, 2008
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IN THIS WEEK'S ISSUE
» News
-- Cream Cheese, Seafood Operations Closed Following Repeat Violations
-- Texas Seafood Processor Ordered to Shut Down, Recall Products
-- Maker, Distributor of Cough and Cold Products Barred After Violations
» Consumer Health Information Cream Cheese, Seafood Operations Closed Following Repeat Violations FDA has announced the shutdown of cream cheese and seafood operations at Illinois-based Lifeway Foods Inc. and its subsidiary, LFI Enterprises Inc., until they comply with food safety laws.
Texas Seafood Processor Ordered to Shut Down, Recall Products
FDA has directed Texas-based Hope Food Supply Inc. to shut down and recall all seafood products manufactured from its facility since 2007. An earlier consent decree required the company to develop and implement an adequate Hazard Analysis and Critical Control Point (HACCP) plan for its fish and fishery products. Because the company has not developed this plan., it cannot restart manufacturing until an FDA-approved HACCP plan is in place. Seafood processors must implement adequate HACCP plans that identify all food safety hazards likely to occur for each kind of seafood product that they process, and set forth preventive measures to control those hazards.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01836.html
Maker, Distributor of Cough and Cold Products Barred After Violations
Scientific Laboratories Inc. and two company executives are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products. Scientific Laboratories is a contract manufacturer and distributor of various prescription cough and cold products. FDA had warned the company against violating food and drug law and about the risk of enforcement action if it failed to take corrective measures.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01837.html
To access the RSS feed of FDA news releases, go to
http://www.fda.gov/bbs/topics/news/rssPress.xml.
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
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CONGRESSIONAL TESTIMONY
May 14 -- FDA Center for Food Safety and Applied Nutrition Director Stephen F. Sundlof, D.V.M., appeared before the House Subcommittee on Health
Subject: “Discussion Draft of the ‘Food and Drug Administration Globalization Act’ Legislation: Device and Cosmetics Safety”
http://www.fda.gov/ola/2008/devices051408.html
May 14 -- FDA Associate Commissioner for Science Norris Alderson, Ph.D., appeared before the House Subcommittee on Consumer Affairs, Insurance, and Automotive Safety
Subject: safety of bisphenol-A (BPA)
http://www.fda.gov/ola/2008/bpa051408.html
May 14 -- FDA Statement for the Record before the House Committee on Oversight and Government Reform
Subject: "Should FDA Drug and Medical Device Regulation Bar State Liability Claims?"
http://www.fda.gov/ola/2008/stateliability051408.html
To view an archive of past testimony by FDA officials, go to
http://www.fda.gov/ola/listing.html
SAFETY ALERTS/RECALLS
For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated
products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.
To access the RSS feed of FDA recalls information, go to
http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
UPCOMING PUBLIC MEETINGS
May 29 -- Dermatologic and Ophthalmic Drugs Advisory Committee
Under discussion: pending application for new drug proposed to treat inflammation and pain following eye surgery
Location: Rockville, Md.
http://edocket.access.gpo.gov/2008/E8-8351.htm
May 30 -- Science Board to FDA
Under discussion: keeping pace with scientific and technical evolutions in regulatory science
Location: Gaithersburg, Md.
http://edocket.access.gpo.gov/2008/E8-10257.htm
May 30 -- Oncologic Drugs Advisory Committee
Under discussion: pending application for a new drug treatment to increase platelet counts and reduce or prevent bleeding in certain patients
Location: Chicago
http://edocket.access.gpo.gov/2008/E8-10258.htm
For a complete list of upcoming meetings, seminars, and other public events sponsored
or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html.
This week's spotlight consumer updates are:
http://www.fda.gov/consumer/updates/asthmameds051308.html
http://www.fda.gov/consumer/updates/ibsdrug050108.html
To receive all consumer updates by e-mail, go to http://www.fda.gov/consumer/consumerenews.html.
For the latest in consumer health news from FDA, visit http://www.fda.gov/consumer/default.htm.
Thanks for subscribing to FDA News Digest.
Updates : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 19 May 2008 14:21:34 -0500 (CDT)
Subject: FDA MedWatch- Solodyn (minocycline HCl) Extended Release Tablets: Recall Of Certain Lots Because One Bottle Of Solodyn Contained Azasan
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Medicis and FDA notified healthcare professionals of the recall of lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of Solodyn Extended Release Tablets. The product was recalled because one of the bottles contained Azasan (azathioprine tablets) 75mg instead of Solodyn 90mg Tablets. Azasan is an immunosuppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis. Taking Azasan instead of Solodyn presents a health hazard and safety risk to patients. Side effects associated with the use of Azasan, particularly in the elderly, include myelosuppression, infection, bleeding, chills, nausea, vomiting and diarrhea. Joint and muscle pain are also common side effects. Additionally, unanticipated interactions with other drugs may also lead to serious adverse events. The recall is limited to the lots referenced above. Healthcare professionals are urged to check their inventory and pull the referenced lot numbers from their stock and make arrangements with the manufacturer to return the product.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Solodyn
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