Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL — Class II drug recall D-0733-2018
Terminated recall by Vitalab Pharmacy, Inc, reported 2018-05-16, distributed nationwide. Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it
| Recall number | D-0733-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vitalab Pharmacy, Inc, Phoenix, AZ, United States |
| Recall initiated | 2018-04-24 |
| Classified | 2018-05-09 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-01-23 |
| Distributed | Nationwide (US) |
| Quantity | 60 vials |
| Reason classes | sterility |
| Lot numbers | T101, T104, T105, T106 |
| Expiration dates | 2018-06-04 |
Product
Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 25mcg/mL, sterile injectables, Vitalab Pharmacy, Inc
Reason for recall
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
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-0733-2018. 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.