FDA Drug recall D-765-2013
Papaverine 40 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
- FDA Drug
- Class II
- ongoing
- Published 2013-07-17
On 2013-07-17 the FDA classified a Class II recall of Papaverine 40 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL by Lowlite Investments, citing lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-765-2013 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2013-05-29 |
| Published | 2013-07-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Lowlite Investments |
| Distribution | US |
Product
Papaverine 40 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Identifiers
| code_info | B0021 Exp 8/31/13, B0013 Exp 8/1/13, C5122 Exp 9/22/13, C51101 Exp 8/1/13, C5508 Exp 9/8/13, and C5119 Exp 9/19/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-765-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.