RC 20-060 - Amneal - Nizatidine - NYC - Consumer


URGENT: MARKET RECALL


  

Description NDC Lot# Exp/Date
NIZATIDINE ORAL SOLUTION 15MG/ML  60846030115 06599002A 12/31/2020
NIZATIDINE ORAL SOLUTION 15MG/ML  60846030115 06599001A 12/31/2020
NIZATIDINE ORAL SOLUTION 15MG/ML  60846030115 06598004A 4/30/2020



AMNEAL PHARMACEUTICALS, LLC is voluntarily recalling NIZATIDINE ORAL SOLUTION, 15 MG/ML distributed under the GEMINI LABORATORIES label. This recall is being issued due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA. This voluntary recall is being made to the Consumer Level and affects the NDC and the lots identified. Affected product started shipping January 2019.

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


This recall is being conducted with the knowledge of the Food & Drug Administration.

Contact:

Amneal: Amneal Drug Safety 877-835-5472