Human Chorionic Gonadotropin recalled over sterility concerns
- Recall date
- April 2, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Complete Pharmacy and Medical Solutions LLC recalls Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solut…
- Recall number
- D-0918-2017
- FDA classification
- Class I
- Brand / firm
- Complete Pharmacy and Medical Solutions LLC
- Sold / distributed
- Nationwide and Puerto Rico
Why it was recalled
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
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