FDA recall D-0698-2017

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.

Reason for recall

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-04-28

Report date

2017-05-17

Termination date

2018-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0698-2017