FDA Drug recall D-0330-2017
QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 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 QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 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-0330-2017 |
| 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
QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 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: 03292016@12…All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 03292016@12, 0422016@10, 04222016@10, 05052016@33, 05122016@11, 05132016@19, 05242016@2, 06212016@17, 07262016@36, 09072016@21, 09142015@17 b) Known lot code: 03242016@9, 04112016@10, 04212016@19, 05042016@20, 05132016@21, 05202016@71, 06152016@7, 07122016@21, 08032016@17, 09092016@35. |
|---|
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-0330-2017%22
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