Voluntary nationwide recall: Famotidine (Fresenius – November)

Fresenius Kabi USA, LLC is recalling three lots (6133156, 6133194, and 6133388) of Famotidine Injection, USP, 20 mg per 2 mL. Famotidine is used to treat excessive secretion of stomach acid or stomach ulcers.

This drug is being recalled because the level of a bacteria component called endotoxin was higher than the acceptable range in one sample. Using a product with elevated endotoxin may cause nonserious reactions such as chills, change in mental status, change in breathing status, fever, increase in body temperature, shivering, and shaking. It may also cause severe reactions such as sepsis and septic shock or may lead to death.

As of Nov. 7, the nonserious reactions mentioned above were reported with one lot. There had been no reports of adverse events related to the second and third lots.

To see if your medication was recalled, contact your doctor or pharmacy where you received it or visit the FDA website below. If you have an affected lot of Famotidine or are experiencing any problems that may be related to receiving the product, you should stop using it and talk to your doctor.

To learn more about this recall, you can take one or more of the steps below.

• Talk to your doctor or pharmacist.
• Call Fresenius Kabi USA Quality Assurance at 866-716-2459. TTY users should call 711. Help is available Monday through Friday from 8 a.m. to 5 p.m. CST.
• Visit the FDA website.