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Medication Safety Alerts

Lorazepam Oral Concentrate 2mg/mLVoluntary Recall

8/16/2017

On August 16, 2017, the United States Food and Drug Administration (FDA) issued a notice about a voluntary recall of Lorazepam Oral Concentrate 2mg/mL. This recall was issued because the dropper markings may be wrong or missing on some plastic droppers supplied with the product. If the markings are wrong or missing, this could cause you to take too much medicine or too little medicine.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

This recall affects the following lot numbers:

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

To see if you have affected product, please check the lot number. The lot number is located on the bottom-right side of the blue and white label, on the amber bottle supplied with the dropper. If your product is not from the lot numbers mentioned above, it is not affected by this recall.

If you have the impacted lot, please contact Amneal Pharmaceuticals at 1‑877‑835‑5472 to request a replacement dropper.

You should not continue to use a dropper that is affected by this recall. Please call your doctor right away for advice if you may be using affected product. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

CVS Caremark Response: If you are currently taking Lorazepam Oral Concentrate 2mg/mL, please call a Customer Care representative toll-free at 1-866-823-5184.

If you are currently taking Lorazepam Oral Concentrate 2mg/mL and have questions regarding this recall, please call your doctor or 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 toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.

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