The Food and Drug Administration (FDA) is alerting healthcare professionals and consumers of a voluntary recall of 3 lots of Amneal’s Nizatidine Oral Solution (15mg/mL) due to potential contamination with N-Nitrosodimethylamine (NDMA), a probable human carcinogen.
The 3 recalled lots of Nizatidine Oral Solution (15mg/mL), NDC# 60846-301-15 include:
- Lot Number: 06598004A; Expiration Date 04/2020.
- Lot Number: 06599001A; Expiration Date 12/2020.
- Lot Number: 06599002A; Expiration Date 12/2020.
Nizatidine, an H2 blocker, is indicated for the short-term and maintenance treatment of duodenal ulcer; for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to gastroesophageal reflux disease (GERD); and for the treatment of active benign gastric ulcer.
Amneal is notifying its customers by mailing a recall notification letter and is arranging for the return of all recalled products. At this time, the Company has not received any reports of adverse events directly related to this recall. Adverse reactions may be reported to the FDA’s MedWatch program.
The FDA continues to advise manufacturers to recall products if NDMA levels are found to be above the acceptable daily intake limit of 0.096micrograms/day. Laboratory results showing NDMA levels for certain ranitidine and nizatidine products can be found here.
Recently, the Agency announced that all prescription and over-the-counter ranitidine products were to be removed from the market after new data showed an increased risk to the public due to NDMA.
For more information visit fda.gov.