Class II
Terminated
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.
- Company
- Par Sterile Products Llc
- Recall Initiated
- April 28, 2017
- Posted
- May 17, 2017
- Recall Number
- D-0698-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 122,469 cartons
- Firm Location
- Rochester, MI, United States
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
Lot / Code Info
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.
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