FDA Drug recall D-0383-2017
QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, 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 QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, 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-0383-2017 |
| 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
QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, 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: 04122016@17,…All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04122016@17, 04142016@14, 05112016@23, 06072016@17, 06232016@13, 07122016@41, 08052016@12 b) Known lot code: 03242016@8, 04142016@15, 05032016@11, 05262016@12, 06242016@11, 07122016@42, 08052016@11. |
|---|
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-0383-2017%22
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