Par Pharmaceutical is conducting a voluntary drug recall of specific lots of Buprenorphine HCI Injection 0.3mg/ml. In some of the vials, Par has identified the potential for the presence of white, crystalline particulates, which are comprised of components or a component of the drug product formulation, principally dextrose and the Buprenorphine active component. The particulates are not free-floating, but rather adhered to the side and bottom of the glass vials.
The affected item is Buprenorphine HCI Injection, 0.3mg/ml (NDC 42023-179-05).
The following lot numbers are affected:
Please check your inventory to see if you have any of the affected lots in stock. If so, please remove them from your inventory and complete this form to return the recalled items to MWI.
Important: Once you have returned the vials, be sure to update your use log(s) to document this change in inventory:
- Enter the number of vials returned
- Enter the number remaining as your balance
- Add a note regarding the recall in the Comments column and file a copy of the completed recall form with the affected/associated use log(s).
If you have additional questions, please contact Kelli Christman at firstname.lastname@example.org or call (734) 764-2003.