Buprenorphine HCI Injection (PAR) – Crystallization Risk (2017)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
PAR Sterile Products LLC
Lot Codes / Batch Numbers
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.
Products Sold
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.
PAR Sterile Products LLC is recalling Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x due to Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of pri. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026