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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Amerisource Health Services Recalls One Lot of Famotadine Injection

FOR IMMEDIATE RELEASE -- Columbus, Ohio -- April 29, 2005 -- Amerisource Health Services, DBA American Health Packaging, Columbus, OH announced that it is voluntarily recalling one lot of Famotidine Injection, 20 mg/2 mL (NDC 55390-029-10), Lot# 045715, 180 boxes, exp. 04/06, due to a lack of sterility assurance reported by the original manufacturer’s recall letter of April 19, 2005. American Health Packaging performed secondary packaging on this product which consisted of placing the manufacturer’s sealed vial in a plastic bag.

This prescription product was distributed in October and November, 2004 to AmerisourceBergen, Suwanee, GA, who further distributed the product only to Piedmont Hospital, Atlanta, GA. Customers that have any vials of this lot of Famotidine Injection should discontinue distribution and use of the lot immediately and contact American Health Packaging, Customer Service Department (1-800-707-4621) for a returned goods authorization.

Famotidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication. Non sterility of injectable products can represent a serious hazard to health that can lead to life threatening injuries and death.

American Health Packaging is working with the USFDA on this recall. No serious health or safety reports have been received that are attributed to this situation.

Consumers and health care professionals with questions may contact Robert L. Kavanaugh, VP Regulatory and Quality Assurance, Amerisource Health Services, at 1-800-707-4621 between the hours of 8:00 am and 4:00 pm, Monday through Friday.

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