Papaverine/Phentolamine/PGE-1 Injectable — Class II drug recall D-1386-2015
Terminated recall by Liberty Drug & Surgical, reported 2015-09-02, distributed in NJ, NY. Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable pr
| Recall number | D-1386-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Liberty Drug & Surgical, Chatham, NJ, United States |
| Recall initiated | 2015-06-15 |
| Classified | 2015-08-27 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2018-04-23 |
| Distributed | NJ, NY |
| Quantity | 2 vials |
| Reason classes | sterility |
| Expiration dates | 2015-07-19 |
Product
Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Reason for recall
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
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-1386-2015. 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.