FDA-Drug2017-05-17Class II
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.
PAR Sterile Products LLC
Hazard
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.
Sold states
Nationwide in the USA
Affected count
122,469 cartons
Manufactured in
870 Parkdale Rd, N/A, Rochester, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0698-2017Don't want to check this manually?
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