PRASH 12 — Class II drug recall D-1091-2018
Terminated recall by Ranier's Compounding Laboratory, reported 2018-08-22, distributed in PA. Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to
| Recall number | D-1091-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ranier's Compounding Laboratory, Jeannette, PA, United States |
| Recall initiated | 2018-07-25 |
| Classified | 2018-08-15 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2022-09-01 |
| Distributed | PA |
| Quantity | 1 vials |
| Reason classes | sterility |
Product
PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Reason for recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
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-1091-2018. 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.