Drug 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.
Lots and codes
Lot #: 821102, 821103, Exp 01/18; 821104, 821106, 821107, Exp 02/18; 821108, Exp 03/18; 821884, 821885, Exp 07/18; 821886, 821887, Exp 08/18; 822767, Exp 09/18; 824183, Exp 10/18.
Recall details
- Recalling firm
- PAR Sterile Products LLC, Rochester, MI
- Quantity
- 122,469 cartons
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 28, 2017
- Terminated
- March 29, 2018
Related products
- Buprenorphine Hydrochloride – drug information
- NDC 42023-179 Buprenorphine Hydrochloride · Buprenorphine Hydrochloride .324 mg/mL · Par Health USA, LLC