June 21, 2001Morton Grove Pharmaceuticals
Inc. Recalls Hydrocortisone and Acetic Acid OTIC Solution
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.
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.