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.
Check against the official notice below — it lists the full affected range.
PAR Sterile Products LLC is recalling Buprenorphine HCI Injection, 0.3 mg/mL in 1 mL single dose vials distributed nationwide in the USA. The recall affects 122,469 cartons across multiple lot numbers with expiration dates ranging from January 2018 through October 2018. The vials contain white, crystalline particulates adhered to the side and bottom of the glass, composed principally of dextrose and the buprenorphine active component.
The recall was issued due to the crystallization of these particulates within the vials. The source document does not specify a remedy or corrective action for consumers who have obtained this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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 Quantity: 122,469 cartons 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.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.