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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
June 24, 1998

Product
a) Cyclomydril (cyclopentotate hydrochloride, phenylephrine hydrochloride) a prescription Sterile Opthalmic Solution packaged in 2 ml and 5 ml plastic DROP-TAINER dispensers. Indications and Usage: Production of mydriasis (dilation of the pupil of the eye). NDC 0065-0359-02 (2 ml), NDC 0065-0359-05 (5 ml)

b) Epinal 1% (epinephryl borate) a prescription Sterile Opthalmic Solution in 7.5 ml glass bottles with sterile dropper assembly. Indications and Usage: Control of simple (open angle) glaucoma; may be used in combination with miotics, beta blockers, hyperosmotic agents, or carbonic anhydrase. NDC 0065-0264-07

c) Mydfrin 2.5% (Phenylephrine Hydrochloride Opthalmic Solution) in 3 ml plastic DROP-TAINER dispensers Indications and Usage: Recommended as a vasoconstrictor, decongestant, and mydriatic in a variety of opthalmic conditions and procedures. NDC 0065-0342-03.

Recall #D-177/179-8.

CODE

               Lot Code  Expiration Date
Cyclomydril         AAFP      8/31/98
(National)          ACFT      11/30/98
                    ADL7      4/30/99
                    AFDH      5/31/99
                    AFZA      9/30/99
                    AHYA      11/30/99
                    AHWX      12/31/99
                    AKAP      2/28/2000
                    AKWM      4/30/2000
Cyclomydril         AAMA 
(International)     ADHP
                    AHYAA
                    AKWMA
Epinal 1%           AH87      1/31/99
Mydfrin 2.5%        6FXA      5/31/98
                    6FXF      5/31/98
                    AAFL      8/31/98
                    AAYA      9/30/98
                    ACZ3      12/31/98
                    ACZ9      1/31/99
                    AC75      2/28/99
                    ADL3      3/31/99
                    AFC5      5/31/99
                    AFMU      7/31/99
                    AFY9      8/31/99
                    AHCY      8/31/99
                    AHCZ      10/31/99
                    AHC1      11/30/99
                    AHWP      11/30/99
                    AHWN      1/31/2000
                    AHWW      1/31/2000
                    AKAU      3/31/2000
                    10913F    4/30/2000.

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

RECALLED BY
Manufacturer, by letter on May 22, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
a) Nationwide and international; b&c) Nationwide.

QUANTITY
a) 238,758 units; b) 3,838 units; c) 840,756 units were distributed.

REASON
Contamination - Some units could contain microscopic particles from the lining (glass) of the manufacturing vessel.

 

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.