D-0698-2017 Class II Terminated
FDA drug recall D-0698-2017 was initiated by PAR Sterile Products LLC on April 28, 2017 and is designated Class II. 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 com… The recall status is terminated (terminated March 29, 2018). Affected quantity: 122,469 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- May 17, 2017
- Initiation Date
- April 28, 2017
- Termination Date
- March 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 122,469 cartons
Product Description
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 Pattern
Nationwide in the USA
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.