[U.S. Food and
Drug  Administration]

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This is the retyped text of a drug recall from Hollister-Stier Laboratories LLC. Contact the company for a copy of any referenced enclosures.


Bayer Corporation

Ana-Kit® Anaphylaxis Emergency Treatment Kit

Item #.

6800ZA or 786807

AK344, AK345, AK346, AK347, AK348, AK349, AK350, AK351 AK352, AK353, AK354, AK355, AK356, AK357, AK358, AK359, AK360, AK361, AK362, AK363, AK366

Lot numbers are located on the Ana-Kit box label.



Bayer Corporation

Ana-Guard® Epinephrine Injection, USP (1:1000)

Item #

6815ZA or 786815

G00196 thru G00220 (inclusive)
G00222, G00223

Lot numbers are located on shoulder of Ana-Guard carrying case or on the side of the individual box or six pack.



Wyeth-Ayerst Laboratories is voluntarily recalling several lots of their Epinephrine Injection product (1:1000). They observed some discolored products in their finished product stability program. A few of these samples were found to be subpotent which may suggest potential health hazard. Please refer to the attached Wyeth-Ayerst Urgent Drug Recall.

Hollister-Stier Laboratories LLC, formerly a Bayer Corporation Pharmaceutical Division company acquired the product line of Ana-Kit and Ana-Guard which utilizes Wyeth-Ayerst's Epinephrine Tubex in the manufacture of Ana-Kit, Ana-Guard and Epinephrine refills. The Ana-Kit and Ana-Guard products are typically carried by patients for emergency self-treatment. The lots listed above utilized Wyeth-Ayerst Tubex lots, and are the only lots involved in this recall.

The attached list specifies those lots that our records indicate were supplied to you. This is to assist you in checking your stock, and in notifying your accounts.

If you have distributed any of these lots, please immediately contact your accounts to advise them of the recall situationm, and have them return their outstanding recalled stocks to you.

Physicians and pharmacists should make every effort to contact patients who may be in possession of these products to have them promptly returned to you for immediate replacement.

Please return the enclosed card immediately providing the requested information.

If you have products affected by the recall, or if customers have returned product to you, please return them via parcel post, UPS or other means, to the following address. Please complete the enclosed Authorized Return form and include it with your return to ensure proper credit.

Recall Coordinator
Hollister-Stier Laboratories LLC
3525 N. Regal Street
Spokane, WA 99207-5788

Your account will be reimbursed by check or credit memo for the returned goods and all shipping costs.

This recall is being made with the knowledge of the Food and Drug Administration. A representative of the Agency may contact you to confirm the compliance with the program outlined above.

Because of the urgent nature of this recall and the critical use of the product involved, strict compliance is requested. As a health care professional, you are an important Hollister-Stier customer. We apologize for the inconvenience and appreciate your immediate assistance and reply to this request.

For assistance and questions concerning the recall please call 1-800-225-6443.

Hollister-Stier Laboratories LLC


Hollister-Stier Laboratories LLC
P.O. Box 3145
Spokane, WA 98220-3145

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