FDA Drug recall D-0004-2017
Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shop…
- FDA Drug
- Class II
- terminated
- Published 2016-10-12
On 2016-10-12 the FDA classified a Class II recall of Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shop… by The Apothecary Shoppe, citing lack of Assurance of Sterility; medication was sterilized with a recalled filter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0004-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-12 |
| Published | 2016-10-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | The Apothecary Shoppe |
| Distribution | OK |
Product
Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Reason
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Identifiers
| code_info | 07252016@22 BUD 09/22/2016; 08102016@28 BUD 10/08/2016 |
|---|
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-0004-2017%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.