PYRIDOXINE HCL — Class II drug recall D-0041-2022
Terminated recall by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy, reported 2021-11-03, distributed in AZ, CA, FL, MN, MT, TX, UT. Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
| Recall number | D-0041-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy, Mesa, AZ, United States |
| Recall initiated | 2021-08-13 |
| Classified | 2021-10-26 |
| Reported by FDA | 2021-11-03 |
| Terminated | 2023-04-12 |
| Distributed | AZ, CA, FL, MN, MT, TX, UT |
| Reason classes | sterility |
Product
PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx
Reason for recall
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0041-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.