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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.

PRODUCT
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.

CODE
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.

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

RECALLED BY
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.

DISTRIBUTION
Puerto Rico.

QUANTITY
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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