FDA-Drug2017-01-11Class II

QUAD2 (PAP/PHEN/ALPROS/ATRO) 9 mg/1 mg/10 mg/0.1 mg/mL Injectable a) 2 mL and b) 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Hazard

Lack of Assurance of Sterility

Sold states
Nationwide
Affected count
a) 191 vials and b) 794 vials
Manufactured in
1210 SW 33rd Ave, N/A, Ocala, FL, United States
Products
QUAD2 (PAP/PHEN/ALPROS/ATRO) 9 mg/1 mg/10 mg/0.1 mg/mL Injectable a) 2 mL and b) 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0384-2017

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