Lorazepam Is Voluntarily Recalled by Maker

Thirteen lots of Lorazepam Oral Concentrate have been voluntarily recalled by Amneal Pharmaceuticals due to defects in dropper markings. Lots affected by the defects can be identified by the lot number printed on the bottom-right side of the blue and white label with the Amneal logo on the bottle and carton. Affected lot numbers include 06876016A, 06876017A, 06876018A, and 06876019A. A complete list is available on the US Food and Drug Administration’s website.

Lorazepam Oral Concentrate, indicated for the management of anxiety disorders, is recommended to be administered at a dose of 2 mg/mL using the packaged dosing dropper. However, the droppers have defects where markings are in reverse number order, have no dose markings, or have shifted dose markings. Errors in dropper markers could result in the administration of medication that is less than or more than the prescribed dose. Serious adverse effects can occur if the administered dose is more than prescribed.
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_____________________________________________________________________________________________________________________________________Currently, no adverse events associated with the defective dropper markings have been reported.

Pharmacies will be provided a recall letter with replacement droppers. The dropper included in the recalled lots should be discarded and replaced with the new dropper. Boxes should be marked with a sticker to indicate the dropper has been replaced. In addition, patients impacted by the recall should be notified to discontinue using the defective dropper and to exchange it for a new one.

—Melissa Weiss

Reference:

Amneal Pharmaceuticals issues voluntary nationwide recall of Lorazepam Oral Concentrate, USP 2mg/mL, due to misprinted dosing droppers supplied with the product [press release]. Bridgewater, NJ: US Food and Drug Administration; August 17, 2017. https://www.fda.gov/Safety/Recalls/ucm571787.htm. Accessed August 17, 2017.