Calcium Gluconate 2 — Class II drug recall D-1509-2016
Terminated recall by W & C dba The Apothecary, reported 2016-09-28, distributed in MN. Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluc
| Recall number | D-1509-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | W & C dba The Apothecary, Sartell, MN, United States |
| Recall initiated | 2016-06-20 |
| Classified | 2016-09-16 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2017-04-19 |
| Distributed | MN |
| Quantity | 840 ml |
| Reason classes | sterility |
Product
Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Reason for recall
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
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-1509-2016. 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.