FDAApril 28, 2017drug

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 recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

par sterile productsparpar sterile

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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