Hydroxyprogesterone 250 mg/ml — Class II drug recall D-646-2013
Terminated recall by Clinical Specialties Compounding Pharmacy, reported 2013-07-10, distributed in FL, GA, SC. Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control process
| Recall number | D-646-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clinical Specialties Compounding Pharmacy, Augusta, GA, United States |
| Recall initiated | 2013-03-20 |
| Classified | 2013-07-03 |
| Reported by FDA | 2013-07-10 |
| Terminated | 2017-02-22 |
| Distributed | FL, GA, SC |
| Reason classes | sterility |
| Expiration dates | 2013-04-04, 2013-04-08, 2013-04-18, 2013-05-05, 2013-05-20 |
Product
Hydroxyprogesterone 250 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Reason for recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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-646-2013. 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.