March 15, 2000Thames 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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