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Recall 2017-141A: Amneal - Lorazepam - NYC - Consumer


URGENT!!!            ESCALATED TO CONSUMER LEVEL!!!            URGENT!!!

NDC                    Label Name                                                               Lots            Expiration
65162068784    LORAZEPAM 2 MG/ML ORAL CONCENTRATE    06877003A    3/31/2019
65162068784    LORAZEPAM 2 MG/ML ORAL CONCENTRATE    06877002A    2/28/2019
65162068784    LORAZEPAM 2 MG/ML ORAL CONCENTRATE    06877001A    2/28/2019
65162068784    LORAZEPAM 2 MG/ML ORAL CONCENTRATE    06876025A    12/31/2018
65162068784    LORAZEPAM 2 MG/ML ORAL CONCENTRATE    06876024A    12/31/2018
65162068784    LORAZEPAM 2 MG/ML ORAL CONCENTRATE    06876023A    11/30/2018
65162068784    LORAZEPAM 2 MG/ML ORAL CONCENTRATE    06876022A    9/30/2018
65162068784    LORAZEPAM 2 MG/ML ORAL CONCENTRATE    06876021A    9/30/2018
65162068784    LORAZEPAM 2 MG/ML ORAL CONCENTRATE    06876020A    9/30/2018
65162068784    LORAZEPAM 2 MG/ML ORAL CONCENTRATE    06876019A    9/30/2018
65162068784    LORAZEPAM 2 MG/ML ORAL CONCENTRATE    06876018A    8/31/2018
65162068784    LORAZEPAM 2 MG/ML ORAL CONCENTRATE    06876017A    8/31/2018
65162068784    LORAZEPAM 2 MG/ML ORAL CONCENTRATE    06876016A    8/31/2018

Amneal is voluntarily recalling the above item/lots due to a potential for a dropper defect in that the dropper may be void of markings or the calibration marking may be in reverse order.   This recall is to the consumer level.  Affected product started shipping November 3, 2016.

Consumers with questions regarding this recall can contact Amneal Pharmaceuticals at 631.952.0214 x338 or amnealreg@amneal.com on Monday through Friday from 9AM through 5PM Eastern Time. 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 FDA.
Information contained in this document was provided by Amneal.

Contact:

Amneal Pharmaceuticals: Amneal Customer Service 631-952-0214