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March 15, 2000

Thames Pharmacal Recalls Major, Schein and Qualitest Acetic Acid Otic Solution

Ronkonkoma, NY (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Thames Pharmacal Company, Inc. is recalling Acetic Acid Otic Solution sold under the Major, Schein and Qualitest labels because of Subpotency (15 month stability).

The recalled Acetic Acid Otic Solution (USP, 2%, in 15 mL units) is a prescription non-aqueous solution used as an antibacterial and anti-fungal agent in the external ear canal.

Over 73,000 units were distributed Nationwide.  The Major brand is NDC 0904-0315-35, Schein NDC 0364-0732-72 and Qualitest is NDC 0603-7035-41.  Each bear one of the following Lot Numbers:
M235 EXP 4/00,
M529, EXP 7/00,
M558 EXP 8/00
M583 EXP 9/00,
M655 EXP 1/01,
M854 EXP 5/01.

The firm estimated that 25 percent of product remained on market at time of recall initiation.

This ongoing Class III recall was initiated by Thames Pharmacal Company by letter faxed on November 9, 1999, and by mail on November 11-12, 1999.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-249-0

Notice of this product warning was sent via email to SafeMail subscribers March 15, 2000.

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Health Professional:

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During 2000 there were over
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