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March 15, 2000

Thames Pharmacal Recalls Thames and Qualitest Hydrocortisone (1%) and Acetic Acid (2%) Otic Solution

Ronkonkoma, NY (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Thames Pharmacal Company, Inc. is recalling Hydrocortisone (1%) and Acetic Acid (2%) Otic Solution sold under the Thames and Qualitest labels because of Subpotency (18 month stability).

The recalled Hydrocortisone (1%) and Acetic Acid (2%) Otic Solution (USP, in 10 mL bottles) is a prescription non-aqueous solution used as an antibacterial and anti-fungal agent in the external ear canal.

Over 91000 units were distributed Nationwide.  Thames label is NDC #49158-197-43, and Qualitest label is NDC #0603-7036-39.  Each bear one of the following Lot Numbers:
M494 EXP 12/99,
M501 EXP 12/99,
M530 EXP 2/00,
M568 EXP 9/00,
M581 EXP 9/00,
M644 EXP 11/00
M775 EXP 3/01.

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 fax letter dated September 24, 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-248-0

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

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Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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