Reported May 17, 2017 · 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…
PAR Sterile Products LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PAR Sterile Products LLC · 870 Parkdale Rd · Rochester, MI · 48307-1740
Is this the product you have?
- 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 byPar Pharmaceuticals Companies, Inc., Spring Valley, NY 10977
- Lot codes and dates
Lot #: 821102821103Exp 01/18821104821106821107Exp 02/18821108Exp 03/18821884821885Exp 07/18821886821887Exp 08/18822767Exp 09/18824183Exp 10/18
- Amount recalled
- 122,469 cartons
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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