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September 27, 2000

Homatropine Hydrobromide Ophthalmic Solution Recalled

Duluth, GA (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Ciba Vision Ophthalmic (CVO) is recalling its Homatropine Hydrobromide Ophthalmic Solution, USP, 5% Dropperettes, 1 ml, Rx because the products potency was not within USP specifications (stability).

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

Homatropine Hydrobromide Ophthalmic Solution, USP, 5% Dropperettes, 1 ml, Rx for treatment of itritis an diridocyclitis, for relief of cillary spasm, and also as an aid in refraction. NDC #58768-778-12.

Recall #D-469-0.

Lot Numbers and EXP Dates: W152 AUG-00, X2123 MAR-01, X2124 AUG-01, X2125 AUG-01, X2126 SEP-01, X2127 SEP-01, X2128 OCT-01, X2129 OCT-01.

OMJ Pharmaceuticals (OMJ), San German, Puerto Rico.

Ciba Vision Ophthalmic (CVO), Duluth, Georgia (distributor of finished product, responsible for labeling text), by letter on or about September 1, 2000. Firm-initiated recall ongoing.

Puerto Rico.

8,229 units were distributed.

Questions concerning this recall should be directed to FDA at 1-888-463-6332

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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