Drug Safety Alerts

Lorazepam Oral Concentrate, USP 2mg/mL Consumer-level Recall

8/16/2017

On August 16, 2017, the United States Food and Drug Administration (FDA) issued a MedWatch regarding a consumer-level recall of Lorazepam Oral Concentrate, USP 2mg/mL. This recall was issued due to a defect in the dropper markings. The Lorazepam Oral Concentrate, USP 2mg/mL, product is packaged with a dosing dropper, supplied to Amneal by a third party. In a few instances, the dropper is printed with the dose markings in reverse number order, has no dose markings or has dose markings that are shifted.

It is packaged in an individual carton, identified with the code NDC 65162-0687-84, which contains a 30 mL amber glass bottle of liquid produced by Amneal, a package insert with patient information, and a plastic dropper sealed in a clear plastic bag.

There is a significant likelihood that the dropper marking errors will result in dispensing either less than, or more than, the prescribed dose. There is a significant probability of a serious health consequence if more than the prescribed dose is dispensed and potential serious adverse events include: drowsiness causing trauma; increased anxiety; increased accidental injury to self or others (e.g., hip fracture, motor vehicle accident); which in the most serious circumstances could result in permanent decreased function or death.To date no adverse events related to these dropper defects have been reported to Amneal.

Amneal is asking pharmacists to instruct all consumers to discontinue use of a defective dropper. Consumers can call Amneal Pharmaceuticals directly at 1 (877) 835-5472 to request a replacement dropper or contact the pharmacy that dispensed their prescription for assistance.

The following lots are affected by this recall:

Affected Lots
06876016A exp. 08/2018; 06876017A exp. 08/2018
06876018A exp. 08/2018; 06876019A exp. 09/2018
06876020A exp. 09/2018; 06876021A exp. 09/2018
06876022A exp. 09/2018; 06876023A exp. 11/2018
06876024A exp. 12/2018; 06876025A exp. 12/2018
06877001A exp. 02/2019; 06877002A exp. 02/2019
06877003A exp. 03/2019

The below picture shows examples of a dropper with the correct print, along with examples of droppers with the defects.

CVS Caremark Response: Because of this action, CVS Caremark is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using Lorazepam oral concentrate, USP 2mg/mL to contact their prescriber.

For more information about this recall, please call Amneal Pharmaceuticals at 1-877-835-5472 or visit http://www.amneal.com/news/.

You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.