FDA Drug recall D-0691-2016
papaverine phentolamine, 35 mg/2.5 mg/mL
- FDA Drug
- Class II
- terminated
- Published 2016-02-24
On 2016-02-24 the FDA classified a Class II recall of papaverine phentolamine, 35 mg/2.5 mg/mL by Abbott S Compounding Pharmacy, citing lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0691-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-15 |
| Published | 2016-02-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Abbott S Compounding Pharmacy |
| Distribution | CA |
Product
papaverine phentolamine, 35 mg/2.5 mg/mL; 5 mL unit size; refrigerate,This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Reason
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0691-2016%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.