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

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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