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SafetyAlerts
February 28, 2001

(Rx) Hydrocortisone and Acetic Acid OTIC Solution Recall

Morton Grove, IL (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Morton Grove Pharmaceuticals, Inc. is recalling certain lots of its (Rx) Hydrocortisone and Acetic Acid OTIC Solution because of subpotency-Hydrocortisone (12th month of stability).

This is the first public notice of this Class II recall issued by FDA.

PRODUCT
(Rx) Hydrocortisone and Acetic Acid OTIC Solution, USP, 1%/2%, 10 mL bottle.

Recall #D-095-1.

CODE:
Lot No. 22864, exp. 05/01.

MANUFACTURER:
Morton Grove Pharmaceuticals, Inc., Morton Grove, IL.

RECALLED BY:
Manufacturer, by letter on 1/23/01. Firm-initiated recall ongoing.

DISTRIBUTION:
Nationwide.

QUANTITY:
66581 bottles.

In a separate Class III recall the company is recalling the following:

PRODUCT
(Rx) Hydrocortisone and Acetic Acid OTIC Solution, USP, 1%/2%, 10 mL bottle.

Recall #D-096-1.

CODE:
Lot No. 22900, exp. 05/01; 22725, exp. 02/01; and 22761, exp. 02/01.

MANUFACTURER:
Morton Grove Pharmaceuticals, Inc., Morton Grove, IL.

RECALLED BY:
Manufacturer, by letter on 1/23/01. Firm-initiated recall ongoing.

DISTRIBUTION:
Nationwide.

QUANTITY:
66581 bottles.

REASON:
Degradants; out of specification results during stability testing.

Questions concerning either of these recalls may be directed to the FDA at 1-888-INFO-FDA.

Notice of this product warning was sent via email to SafetyAlerts subscribers February 28, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.

 
Selected Recent Recalls


Health Professional:

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

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.