QUAD3 30 mg/3 mg/30 mcg/ Injectable 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 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, O…
- Recall number
- D-0330-2017
- 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
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
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