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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
August 5, 1998

PRODUCT
Miochol E Intraocular Solution (acetylcholine chloride), 20 mg/2mL vials, Rx, used to obtain miosis of the iris in seconds after delivery of the lens in cataract surgery, in penetrating keratoplasty, iridectomy and other anterior segment surgery where rapid miosis may be required. NDC #58768-773-52 and NDC 58768-773-53. Recall #D-206-8.

CODE
Lot numbers: V2328 EXP 1/99 and V2325 EXP 1/99.

MANUFACTURER
OMJ Pharmaceuticals, San German, Puerto Rico.

RECALLED BY
CIBA Vision Ophthalmics (CVO), Duluth, Georgia, by letter mailed during the month of July 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Undetermined.

REASON
Low pH values (10 month stability test).

 

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.