Cholecalciferol 50 — Class II drug recall D-1450-2015
Terminated recall by The Compounding Pharmacy of America, reported 2015-09-23, distributed nationwide. Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality
| Recall number | D-1450-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Compounding Pharmacy of America, Knoxville, TN, United States |
| Recall initiated | 2015-06-02 |
| Classified | 2015-09-15 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2016-02-10 |
| Distributed | Nationwide (US) |
| Quantity | 102 ml |
| Reason classes | sterility, cgmp |
Product
Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Reason for recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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-1450-2015. 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.