PAR Sterile Products LLC recalls Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials
Recalled May 17, 2017 · FDA recall D-0698-2017 · PAR Sterile Products
Hazard
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component. · FDA Class II
Units
122,469 cartons
Sold at
Nationwide in the USA
Description
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
Product
Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring Valley, NY 10977.
Manufacturer(s)
PAR Sterile Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →