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June 21, 2001

Morton Grove Pharmaceuticals Inc. Recalls Hydrocortisone and Acetic Acid OTIC Solution

Morton Grove, IL (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Morton Grove Pharmaceuticals, Inc. has recalled certain Hydrocortisone and Acetic Acid OTIC Solution because of degradants; Out of specification results during stability testing.

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

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

Recall #D-096-1. EXTENSION.

LOT NO. 22900, 22725, and 22761.

Recall Extended to include lots: 22835A, 22997A, 23026A, 23060A, 23097A, 23160A, 23160C, 23246A, 23287A, 23343A, 23419A, 23419C, 23466A, 23474A, 23474C, 23496A, 23497A, 23497C, 23570A, 23601A, 23627A, 23667A, 23667C.

Morton Grove Pharmaceuticals, Inc., Morton Grove, IL.

Manufacturer, by letter on 4/27/2001. Firm initiated recall is ongoing.


328,022 units.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Notice of this product warning was sent via email to SafetyAlerts subscribers June 21, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.

Selected Recent Recalls

Health Professional:

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

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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.