FDA-Drug2017-01-11Class II

QUAD4 (PAP/PHEN/ALPROS/ATRO) 30 mg/3 mg/60 mcg/0.2 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
114 vials and b) 1,017 vials
Manufactured in
1210 SW 33rd Ave, N/A, Ocala, FL, United States
Products
QUAD4 (PAP/PHEN/ALPROS/ATRO) 30 mg/3 mg/60 mcg/0.2 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-0385-2017

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