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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
December 2, 1998

PRODUCT
Miochol E Intraocular Solution 1:100 with electrolyte diluent (Acetylcholine Chloride), in 20 mg/2mL vials, 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. Recall #D-023-9.

CODE
Lot #V2333 EXP 4/99.

MANUFACTURER
OMJ Pharmaceuticals, San German, Puerto Rico (manufacturer of the finished drug product and an approved testing facility).

RECALLED BY
CIBA Ophthalmics (CVO), Duluth, Georgia, by letter dated September 23, 1998, followed by telephone. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Undetermined.

REASON
Low pH.

 

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.