Medicis Announces Voluntary Recall of Solodyn® (minocycline HCL,
USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038
Due to Product Mix-Up
Contact:
Stericycle Customer Service
1-888-656-6381
FOR IMMEDIATE RELEASE -- SCOTTSDALE, Ariz. -- May
16, 2008 -- Medicis today 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.
AZASAN® is an immuno-suppressive 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 mylosuppression (decrease in the
number of red and white blood cells and platelets), infection,
bleeding, chills, nausea, vomiting and diarrhea. Joint and muscle pain
are also common side effects. Unanticipated interactions with other
drugs may also lead to serious adverse events. SOLODYN® is manufactured
by AAIPharma, Inc. under contract to Medicis. The two lots were
manufactured during February 2008. The recall is limited to these lots,
and ample supplies of SOLODYN® remain on the market.
Any inquiries related to this recall should be addressed to
Stericycle Customer Service at 1-888-656-6381 with representatives
available Monday through Friday, 8 a.m. to 11 p.m. EST. For any medical
information inquiries or to report an adverse event related to this
recall, contact Medicis at 1-800-900-6389 with representatives
available 24 hours a day, 7 days a week.
Health care professionals may continue to prescribe the Medicis brand SOLODYN®.
This recall is being conducted in cooperation with the contract
manufacturer of the products and with the knowledge of the FDA.
Any adverse reactions experienced with the use of this product,
and/or quality problems, also may be reported to the FDA's MedWatch
Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail
at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on
the MedWatch website at www.fda.gov/medwatch.
SOLODYN is a registered trademark of Medicis Pharmaceutical Corporation.
AZASAN is a registered trademark of AAIPharma, Inc.
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