FDA-Drug2017-01-11Class II

QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Hazard

Lack of Assurance of Sterility

Sold states
Nationwide
Affected count
a) 1,312 vials and b) 3,354 vials
Manufactured in
1210 SW 33rd Ave, N/A, Ocala, FL, United States
Products
QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0330-2017

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