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SafetyAlerts
August 14, 2002

Ultraseal Has Recalled Hydrocortisone Cream

(SafetyAlerts) - The Food and Drug Administration (FDA) has released the following information.

PRODUCT
a) Hydrocortisone Cream 1%, 0.9 gram and 1 gram packets.
Recall # D-379-2;
b) Hydrocortisone Cream .5%, 0.9 gram and 1 gram packets.
Recall # D-380-2.
These over-the-counter drugs are sold under the following private labels:
Hydrocortisone Cream USP 1%, 0.9 gram
Manufactured for Just American Safety, Osceola, IN
1% Hydrocortisone Anti-Itch Cream, 0.9 gram
Manufactured for First Aid Direct, Sunrise, FL
Hydrocortisone Cream 1%
Manufactured for Textilease Medique, Skokie, IL
Hydro-Max 1% Hydrocortisone Acetate Cream, 0.9 gm
Manufactured for: AFFIRMED MEDICAL INC., Dallas, TX
Hydrocortisone 1%, 0.9 gm
Manufactured for: ESAFETYCO, Salinas, CA
SWIFT Hydrocortisone Cream USP 1% packets, 1 gm
Dist. by Swift FIRST AID, INC., Valencia, CA
Hydrocortisone Cream, 1/2% and 1%, 1 gm
Distributed by: Moore Medical Corp., New Britian, CT
1/2% NDC #0839-8019-72 and 1% NDC #0839-8020-72
Hydrocortisone 1%, 0.9 gm
Mfg. for American First Aid, Hanover, MD
Hydrocortisone Cream 1%, 1 gm
Dist. by Green Guard First Aid and Safety Service, St. Louis, MO
Respond Hydrocortisone 1% Cream Itch Relief, 1 gm
Manufactured for: Respond Ind., Denver, CO.

CODE
1/2% cream lot numbers:
2238, Exp. 10/02
K-2380, Exp. 6/03
A-K-2445, Exp. 10/03

1% cream lot numbers:
A-K-2331, EXP. 9/02
A-K-2237, EXP. 10/02
A-K-2247, EXP. 11/02
A-K-2251, EXP. 12/02
A-K-2253, EXP. 12/02
A-K-2299, EXP. 1/03
A-K-2318, EXP. 2/03
A-K-2322, EXP. 3/03
A-K-2377, EXP. 5/03
A-K-2380, EXP. 6/03
A-K-2411, EXP. 7/03
A-K-2426, EXP. 9/03
A-K-2468, EXP. 11/03
A-K-2481, EXP. 12/03
A-K-2536, EXP. 2/04
A-K-2578, Exp. 2/04

K-2237, EXP. 10/02
K-2238, EXP. 10/02
K-2247, EXP. 11/02
K-2251, EXP. 12/02
K-2299, EXP. 1/03
K-2322, EXP. 3/03
K-2380, EXP. 6/03
K-2419, EXP. 8/03

247, EXP. 11/02.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Ultraseal Corp., New Paltz, NY, by letters beginning July 5, 2002.
Manufacturer: Ultratab Laboratories, Inc., Highland, NY.
Firm initiated recall is ongoing.

REASON
Subpotent.

VOLUME OF PRODUCT IN COMMERCE
1/2% - 622,944 packets; 1 % - 786,416 packets.

DISTRIBUTION
CA, CO, FL, IL, KS, MD, and MO
.

 
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Health Professional:

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During 2000 there were over
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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.