[U.S. Food and
Drug  Administration]

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This is the retyped text of a letter from Wyeth-Ayerst. Contact the company for a copy of any referenced enclosures.


August 19, 1999

URGENT DRUG RECALL Subpotency

PRODUCT:

Epinephrine Injection, USP 1:1000 1 mg/mL Tubex

SIZE:

1 mL Tubex, 10 Tubex per box

NDC:

0008-0263-01

LOT NOS:

2971529 (EXP 11/99); 2971530 (EXP 9/99)
2971534 (EXP 2/00); 2971535 (EXP 3/00)
2971536 (EXP 4/00. 2971538 (EXP 5/00)
2983265 (EXP 7/00)

DISTRIBUTION:

June 1997- February 1999

TO: Wyeth-Ayerst Customers

Wyeth-Ayerst is voluntarily recalling specific lots of Epinephrine Injection, USP 1:1000 in 1 mg/mL Tubex(g). We have observed discolored samples in our finished product stability program. A few of these samples have been found to be subpotent at or near expiration, which may suggest a potential health hazard. You should extend this recall to the hospital pharmacy and physician shelf level.

Please examine your inventory of Epinephrine Injection, USP 1: 1000 in 1 mg/mL Tubex immediately, and follow the appropriate course of action described below.

  1. If you have any of the seven lots listed above, please remove them immediately from sale or use and return all of the above-listed lot numbers to the following location:

    Wyeth-Ayerst Laboratories
    Dock 27
    31 Morehall Road
    Frazer, Pennsylvania 19355
    Attn. V. Murray

    Please complete the enclosed packing slip and include it with your return to ensure proper credit. Please use the enclosed shipping label for ease of handling. You will receive credit for the returned merchandise and you will be reimbursed for the shipping charges.

  2. If you have distributed any of these specific lots to subordinate accounts, please notify them of this recall immediately and request return of the products to you for your consolidated return to us, recall is to be extended to all retail/dispensing, hospital, and physician accounts.

  3. Please mark the appropriate box or boxes on the enclosed pre-paid postcard, record the quantity you will return, and send the postcard to us as soon as possible. Your response, even if YOU do not have nay recalled product from the subject lots is very important to both us and the FDA in monitoring the effectiveness of this recall.

The Food and Drug Administration has full knowledge of this recall. Wyeth-Ayerst apologizes for any inconvenience resulting from this recall. If you have any questions, please call our Product Quality Department at 1-800-999-9384. Thank you for your cooperation.

Sincerely yours,

Anil Sawant, Ph.D.
Assistant Vice President
Quality Assurance


Wyeth-Ayerst Laboratories


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