Amneal announced a voluntary recall of 13 lots of Lorazepam Oral Concentrate 2mg/mL due to an error in the dropper markings.
The dosing droppers, supplied by a third party, were misprinted with the dose markings in reverse number, shifted dose markings or no dose markings. The product was packaged in individual cartons with the NDC 65162-687-84 containing 30mL glass bottles of liquid; the plastic dropper is sealed in a clear plastic bag. The affected product Lot # and expiration dates are as follows:
|
Lot Number |
Expiration Date |
|
06876016A |
08/2018 |
|
06876017A |
08/2018 |
|
06876018A |
08/2018 |
|
06876019A |
09/2018 |
|
06876020A |
09/2018 |
|
06876021A |
09/2018 |
|
06876022A |
09/2018 |
|
06876023A |
11/2018 |
|
06876024A |
12/2018 |
|
06876025A |
12/2018 |
|
06877001A |
02/2019 |
|
06877002A |
02/2019 |
|
06877003A |
03/2019 |
Lorazepam Oral Concentrate, a CIV controlled substance, is indicated for the management of anxiety disorders, for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.
Use of the droppers with marking errors can lead to a dose that is either greater than or less than the prescribed dose. Potentially serious adverse events associated with a higher than prescribed dose include drowsiness causing trauma, increased anxiety, increased accidental injury to self or others (eg, hip fracture, motor vehicle accident), permanent decreased function, or death.
Amneal has notified its wholesalers and pharmacies via a letter arranging for supply replacement. The Company has not received any adverse events related to the defective droppers.
For more information call (631) 952-0214 or visit Amneal.com.
