TOPIC: Three Lots of Famotidine Injection USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial by Fresenius Kabi: Recall - Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples
AUDIENCE: Patient, Health Care Professional, Pharmacy, Gastroenterology
ISSUE: Fresenius Kabi is recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL vial. This recall is being performed to the user level in the United States.
The product is being recalled due to out-of-specification (OOS) endotoxin results of certain reserve samples from a single lot. Based upon the investigation, two additional lots were also included in the recall as a precautionary measure.
Elevated endotoxin levels can precipitate severe systemic reactions such as sepsis and septic shock. Severe responses may include inflammatory and life-threatening immune responses and death. Non-serious adverse event reports potentially associated with the OOS have been received for one lot. These non-serious adverse events included chills, change in mental status, change in respiratory status, fever, increase in body temperature, shivering and shaking.
To date, no adverse event reports have been received for the second and third lots.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: 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 for the following conditions:
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Short term treatment of active duodenal ulcer.
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Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.
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Short term treatment of active benign gastric ulcer.
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Short term treatment of gastroesophageal reflux disease (GERD).
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Treatment of pathological hypersecretory conditions.
RECOMMENDATIONS:
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Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.
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Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459.
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Adverse reactions or quality problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176 or send an e-mail to either productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@fresenius-kabi.com.
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Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall.
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