Drug 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.
D-0698-2017
Product summary
- Event
- Event 77169
- Status
- Terminated
- Classification
- Class II
- Quantity
- 122,469 cartons
- Official record key
drug-enforcement:D-0698-2017
Official wording
Reason: 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.
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.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
particulates