September 27, 2000Homatropine Hydrobromide
Ophthalmic Solution Recalled
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.
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
8,229 units were distributed.
Questions concerning this recall should be
directed to FDA at 1-888-463-6332
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