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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
December 23, 1998
PRODUCT
Miostat (Carbachol 0.01%) Intraocular Solution, in 1.5 ml sterile
glass vials, Rx, for use for obtaining miosis during surgery. 
NDC #0065002315 (United States) and 0065002310 (Canada).
Recall #D-042-9.

CODE
All lots that remain within expiration date (84 lots).

MANFACTURER
Alcon Laboratories, Inc., Fort Worth, Texas.

RECALLED BY
Manufacturer, by letters dated November 16 and 23, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Canada.

QUANTITY
1,981,956 units were distributed; firm estimated that 190,000 units remained on market at time of recall initiation.

REASON
Presence of minute borosilicate flakes.

 

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.