Wells Pharmacy Network product recalled over sterility concerns
- Recall date
- September 21, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Wells Pharmacy Network LLC recalls 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 Pharmac…
- Recall number
- D-0384-2017
- FDA classification
- Class II
- Brand / firm
- Wells Pharmacy Network LLC
- Sold / distributed
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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