FDA Recall Classification Request – Buprenorphine Recall

Original Request: As part of a research study conducted in 2021, we received and used a buprenorphine HCL product (injection, 0.3mg/mL, Lot No: 36227, Exp. Date 02/2023) that was effected by recall number D-0087-2024. The public recall notice (https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=190283) indicates this was a Class II recall due to the presence of white, crystalline product agglomerations. We request any and all information beyond what is provided in the public recall notice that was used by the FDA to inform the Center’s classification of the recall. Specifically, we request documentation of any assessment of the impact of the crystalline agglomerations on the safety or effectiveness of the product that may have been submitted by the company to the FDA.