As with all medical products, healthcare professionals are strongly encouraged to report any serious adverse events that are associated with the use of Gentamicin Sulfate to either the manufacturer (see letter below) or to the FDA's MedWatch program by phone (1-800-FDA-1088), fax (1-800-FDA-0178), internet ( www.fda.gov/medwatch) or mail (using postage-paid form) to FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787

November 30, 1998

Dear Customer/Health Professional:

American Pharmaceutical Partners, Inc. is voluntarily withdrawing all unexpired 40mg/mL lots of the Gentamicin Sulfate Injection, USP. These lots were manufactured by Fujisawa USA, Inc. and by American Pharmaceutical Partners, Inc. and distributed under the Fujisawa Inc. label. A list of product codes, lot numbers, NDC numbers and expiration dates is attached.

The reason for this voluntary withdrawal is an increase in the frequency of reports of adverse reactions to the 40 mg/mL products. The vast majority of reported reactions, where dosing information is available, have been associated with the administration of once-daily dosages of the product. Accordingly, we do not recommend the once-daily dosing of this product.

It is important to note that all batches associated with these adverse events have met all USP specifications. The Food and Drug Administration and American Pharmaceutical Partners are working together to investigate, identify and resolve the causes of these reactions. As soon as the issue has been resolved to the satisfaction of the FDA and APP, manufacturing and distribution of these products will be resumed. We apologize for any inconvenience this may have caused.

To implement this withdrawal, please do the following:

1. Examine your stock immediately to determine if you have any product from the affected lots.

2. If so, immediately discontinue use of the listed lots and return all units to American Pharmaceutical Partners via Federal Express (prepaid airbill enclosed) second day air using the enclosed return goods label and packing slip. A credit memo will be issued covering the quantity of your return to American Pahrmaceutical Partners.

3. PLEASE COMPLETE THE ENCLOSED REPLY AND FAX BACK TO US IMMEDIATELY AT 1-708-3343-1457.

Note: Please continue to report any adverse drug events encountered with these products.

This withdrawal is being made with the knowledge of the Food and Drug Administration.

For medical questions or reporting any adverse events concerning these products, please call APP's Medical Information Department at 1-800-551-7176.

If you have any questions regarding these withdrawal procedures, please call Tony Horton at 1-708-547-2381.

Sincerely,

Tony Horton
Vice President, Corporate Operations QA

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