March 15, 2000Thames 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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