FDA-Drug2017-01-11Class II

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

Wells Pharmacy Network LLC
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide
Affected count
a) 1,165 vials b) 2,217 vials
Manufactured in
1210 SW 33rd Ave, N/A, Ocala, FL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0383-2017

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