C-PAV/PHENTOL/PGE1 recalled over sterility concerns
- Recall date
- July 28, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Colonia Care Pharmacy recalls C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
- Recall number
- D-0208-2017
- FDA classification
- Class II
- Brand / firm
- Colonia Care Pharmacy
- Sold / distributed
- NJ and NY
Why it was recalled
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
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