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US FDA: Nizatidine Oral Solution being recalled due to possible carcinogen

US FDA: Nizatidine Oral Solution being recalled due to possible carcinogen Photo: US FDA.

KAAL-TV
Created: April 18, 2020 07:25 PM

(ABC 6 News) -- The U.S. Food and Drug Administration says a New Jersey based company is recalling three lots of Nizatidine Oral Solution because it contains NDMA which has been found to possibly cause cancer.

FDA says NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.

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The product, manufactured by Amneal Pharmaceuticals, LLC, is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level.

Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The three recalled lots are identified in the table below. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA.

Company officials say they not received any reports of adverse events that have been confirmed to be directly related to this recall.

Nizatidine Oral Solution manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).

The Nizatidine Oral Solution lots subject to the recall can be identified by the NDC number and lot number listed on the product label:

NDC No. Description Lot Expiration Date
60846-301-15 Nizatidine Oral Solution 06598004A 04/2020
60846-301-15 Nizatidine Oral Solution 06599001A 12/2020
60846-301-15 Nizatidine Oral Solution 06599002A 12/2020

The affected Nizatidine Oral Solution lots were distributed directly to wholesalers who further distributed to retail pharmacies and consumers nationwide in the USA.

Amnealis notifying its direct customers by mailing (FED Ex Standard Overnight) a recall notification letter and is arranging for return of all recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Customers who purchased the impacted product directly from Amneal can call Inmar at (855) 319-4807, Monday – Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com for further information. Consumers should contact their physician or other healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Consumers who have Nizatidine Oral Solution which is being recalled should stop using the product and can call Inmar at 855-319-4807, Monday – Friday, 8:00 am – 5:00 pm, EST for further information.

Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


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