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.

FDA recall notice · announced May 17, 2017 · Par Sterile Products

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: 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.
Quantity: 122,469 cartons
Status: Terminated
Products in this recall event:
- 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 Com (D-0698-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.