PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 11, 2017 Initiated: September 21, 2016 #D-0383-2017

Product Description

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 for Recall

Lack of Assurance of Sterility

Details

Units Affected
a) 1,165 vials b) 2,217 vials
Distribution
Nationwide
Location
Ocala, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by Wells Pharmacy Network LLC. Units affected: a) 1,165 vials b) 2,217 vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on January 11, 2017. Severity: Moderate. Recall number: D-0383-2017.