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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
October 7, 1998

PRODUCT
a) Aconite and Iodine Solution (41.6%/58.4%), in 2 fluid ounce containers

b) Parachlorophenol Camphorated, USP, (Camphor 65%/Parachlorophenol 35%), in 1 and 2 fluid ounce, and 1 gallon containers;

c) Desensitizer (Phenol, USP 24.2%, Oil of cloves (22.8%), cassia (5.4%), Eucalyptus (4.0%) Benzocaine, USP 2.0%, in 1 fluid ounce container;

d) Novo Devitalizing Paste (Arsenic Trioxide 38.4% Benzocaine 19.2%,Cresol 4.9%, Creosote 2.5%, Thymal 0.5%), in 6.2 g tube;

e) Formocresol (Cresol 48.5%, Formalin 48.5%, Glycerin 3.0%), in 1 and 2 fluid ounce containers, and in 1 gallon containers;

f) Hemostatic Ferric Swabs, (Ferric subsulfate solution 49.96%, Glycerin USP 49.96%, Phenol USP 0.08%), in 50 and 100 swab bottles;

g) Parachloprophenol, Liquefied (Parachlorophenol 97%), in 7 mL and 1 gallon bottles;

h) Perio-Eze 20 (Benzocaine 20%) in 30 g (paste) tubes;

i) Phenol Compound (Phenol 67.5%, Thymol 16.7% Menthol 8.3) in 1 fluid ounce bottles;

j) Silver Nitrate Ammoniacal (Silver nitrate/Stronger
Ammonia/Water), in 0.5 ounce bottle;

k) Soc-Eze (Blu Pak/Chlorobutanol 4.0%, Balsam Peru 46.0%, Eugenol 46.0%, Benzocaine 4.0%), in 0.5 fluid ounce bottles;

l) Iodoform Aromatic Paste (Zinc Oxide 31.31%, Iodoform 15.78%), in 8 g paste;

m) Gysi's Trio Paste (Barium Sulfate 31.2%, Zinc Oxide 10.2%, Cresol 6.6%), in 11 g paste;

n) Mummifying Paste (Paraformadehyde 3.0%, Thymol 3.0%), in 6 g paste.  Recall #D-249/262-8.

CODE
All lots manufactured at the York, PA facility:

MANUFACTURER
Moyco Technologies, Inc., York, Pennsylvania.

RECALLED BY
Manufacturer, by letter dated May 13, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
Undetermined.

REASON
Current good manufacturing practice deviations.

 

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.