WEEK ENDING NOVEMBER 26

PRODUCT a) Ana-KitÆ Anaphylaxis Emergency Treatment Kit- consisting of 1 syringe (1.0 mL) containing two single doses (0.3 mL) of Epinephrine Injection USP, (1:1000), 4 tablets (Chlorpheniramine Maleate) of antihistamine, and 2 sterile isopropyl alcohol (70%) swabs, labeled in part "Pkgd. and Dist. By: Bayer Corporation Pharmaceutical Division Spokane, WA 99207 ** Epinephrine Mfg by: Wyeth-Ayerst Laboratories Philadelphia, PA 19101***", for treatment of severe anaphylactic or anaphylactoid reactions and severe asthma. Sold as individual kits or 6-packs. NDC 0026-9988-01 and 0026-9988-06;
b) Ana-GuardÆ Epinephrine Injection USP (1:1000)- consisting of 1 syringe (1.0 mL) containing two single doses (0.3 mL) of Epinephrine Injection USP, (1:1000). labeled in part "ANA-GUARD EPINEPHRINE INJECTION, USP (1:1000) ** Pkgd. and Dist. By: Bayer Corporation Pharmaceutical Division Spokane, WA 99207 USA Epinephrine Mfg. By: Wyeth-Ayerst Laboratories Philadelphia, PA 19101***. NDC 0026-9984-01 and 0026-9984-06;
c) Epinephrine Injection, USP (1:1,000) Syringe - a refill item for the above two products sold as 500 syringes/box under NDC# 0026-9982-01 each containing two single doses (0.3 mL) of Epinephrine Injection USP, (1:1000).
CODE Ana-Kit:
AK344 EXP Date 8-99 AK345 EXP Date 8-99
AK346 EXP Date 9-99 AK347 EXP Date 11-99
AK348 EXP Date 1-2000 AK349 EXP Date 5-2000
AK350 EXP Date 9-99 AK351 EXP Date 11-99
AK352 EXP Date 9-99 AK353 EXP Date 5-2000
AK354 EXP Date 6-2000 AK355 EXP Date 6-2000
AK356 EXP Date 7-2000 AK357 EXP Date 9-99
AK358 EXP Date 1-2000 AK359 EXP Date 8-2000
AK360 EXP Date 9-99 AK361 EXP Date 9-99
AK362 EXP Date 11-99 AK363 EXP Date 1-2000
AK366 EXP Date 7-2000
Ana-Guard:
G00196 thru G00203 (inclusive) EXP Date September 1999
G00204 & G00205 EXP Date November 1999
G00206, G00207, G00208 EXP Date January 2000
G00209 EXP Date May 2000
G00210 EXP Date June 2000
G00211, G00212, G00213 EXP Date July 2000
G00214 through G00220 (inclusive), G00222, G00223 EXP Date August 2000
Epinephrine Injection Refills:
S315 EXP Date Aug 1999
S316 through S320 (inclusive) EXP Date Sept 1999
S321, S322, S323 EXP Date Nov. 1999
S324 through S327 (inclusive) EXP Date Jan 2000
S328 through S333 (inclusive) EXP Date May 2000
S334, S335, S336 EXP Date July 2000
S337 through S340 (inclusive) EXP Date Aug 2000.
MANUFACTURERS Epinephrine: Wyeth-Ayerst Laboratories, Philadelphia, Pennsylvania (responsible firm); Ana-Kit and Ana-Guard: Hollister-Stier Laboratories LLC, Spokane, Washington (formerly a Bayer Corporation Pharmaceutical Division Company).
RECALLED BY Hollister-Stier Laboratories LLC., Spokane, Washington
DISTRIBUTION Nationwide and international.
QUANTITY Ana-Kit: 456,036 kits were distributed Ana-Guard: 55,238 kits were distributed Refills: 62,027 distributed
REASON Subpotency of the Epinephrine.

PRODUCT DERM/BURO INSECT STING KIT, Rx - consisting of 1 syringe (1.0 mL) containing two single doses (0.3 mL) of Epinephrine Injection USP, (1:1000), 4 chewable tablets (Chlorpheniramine Maleate) of antihistamine, 2 sterile isopropyl alcohol (70%) swabs and one tourniquet. Per label: "Pkgd. and Dist. by: Derm/Buro Inc., Deerfield, IL 60015".
CODE Derm/Buro KIT Lot #/EXP Date Epinephrine Lot #/EXP Date (in Kit)
#0397, 11/99 2971529, 11/99
#0497, 11/99 2971529, 11/99
#0497, 02/00 2971534, 02/00
#0597, 02/00 2971534, 02/00
#8141, 02/00 2971534, 02/00
#8141, 05/00 2971538, 05/00
#8139, 05/00 2971538, 05/00
#11464, 05/00 2971538, 05/00
#11464, 05/00 2983265, 07/00
#13239, 05/00 2983265, 07/00.
MANUFACTURER Wyeth Ayerst Laboratories, West Chester, Pennsylvania (maker of Epinephrine/responsible firm).
RECALLED BY Derm/Buro, Inc., Plainview, New York (distributor of sting kit)
DISTRIBUTION U.S. government military installations nationwide.
QUANTITY 59,964 kits were distributed.
REASON Subpotency of the Epinephrine.

PRODUCT Epinephrine Injection, USP, 1:1000, Rx, in 1 mg/1 mL Tubex Æ syringes, (25 gauge 5/8 inch needle) units of 10, used to treat respiratory distress in bronchial asthma or during severe, acute asthma attacks, reversible bronchospasms, severe acute anaphylactic reactions, cardiac arrest - to restore cardiac rhythm, and hypersensitivity reactions to drugs, sera, insect stings or other allergens. (NDC# 0008-0263-01) and 50 (NDC# 0008-0263-02).
CODE NDC 0008-0263-01 - Lots: 2971529 EXP 11/99, 2971530 EXP 9/99, 2971534 EXP 2/00, 2971535 EXP 3/00, 2971536 EXP 4/00, 2971538 EXP 5/00, EXP 2983265 EXP 7/00. NDC 0008-0263-02 - Lots: 2971525 EXP 8/99, 2971526 EXP 9/99, 2971531 EXP 11/99, 2971533 EXP 1/00, 2971537 EXP 5/00, 2983255 EXP 6/00, 2983256 EXP 7/00, and 2983257 EXP 8/00.
MANUFACTURER Wyeth Ayerst Laboratories, West Chester, Pennsylvania.
RECALLED BY Wyeth Ayerst Research, inc., Radnor, Pennsylvania
DISTRIBUTION Nationwide and Sweden.
QUANTITY 516,610 tubex/syringes of NDC 0008-0263-01 and 651,600 tubex/syringes of NDC 0008-0263-02 were distributed.
REASON Subpotency.