FDA Drug recall D-0407-2017
Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
- FDA Drug
- Class II
- terminated
- Published 2017-01-11
On 2017-01-11 the FDA classified a Class II recall of Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL by Wells Pharmacy Network, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0407-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-21 |
| Published | 2017-01-11 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Wells Pharmacy Network |
| Distribution | US |
Product
Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04072016@10,…All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04072016@10, 05102016@18, 06232016@12, 08182016@26 b) Known lot code: 04122016@19, 05042016@18, 06142016@43, 07122016@40, 07262016@47. |
|---|
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-0407-2017%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.