HCG 11 — Class II drug recall D-0263-2017
Ongoing recall by Tri-Coast Pharmacy, reported 2017-01-11, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0263-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tri-Coast Pharmacy, Juno Beach, FL, United States |
| Recall initiated | 2016-11-17 |
| Classified | 2017-01-04 |
| Reported by FDA | 2017-01-11 |
| Distributed | Nationwide (US) |
| Quantity | 5,229 vials |
| Reason classes | sterility |
| Lot numbers | 000IU, 06152016A, 07112016C, 07252016D, 08052016A, 08092016D, 08262016B, 08312016B, 09072016A, 09222016D, 09282016B, 10102016H, 10182016D, 10252016J, 11012016E, 11042016A |
Product
HCG 11,000 IU Vial. Compounded by Tri-Coast Pharmacy
Reason for recall
Lack of Assurance of 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-0263-2017. 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.