Class II · Moderate risk
Human Chorionic Gonadotropin 1
CGMP deviations: Lack of potency testing.
Human Chorionic Gonadotropin
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
- Recalling firm
- Complete Pharmacy and Medical Solutions LLC
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0917-2017 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other recalls by Complete Pharmacy and Medical Solutions LLC
All 2015 recalls
Class II · Moderate risk
Human Chorionic Gonadotropin 5
CGMP deviations: Lack of potency testing.
Class II · Moderate risk
Human Chorionic Gonadotropin 6
CGMP deviations: Lack of potency testing.
Class II · Moderate risk
Human Chorionic Gonadotropin 11
CGMP deviations: Lack of potency testing.
Other sterility / contamination recalls from 2015
All sterility / contamination recalls
Class II · Moderate risk
Baclofen
Lack of assurance of sterility
Class II · Moderate risk
IT Custom Compound
Lack of Assurance of Sterility
Class II · Moderate risk
Baclofen 1 mg/ml in 40 ml NS syringe
Lack of Assurance of Sterility
Class II · Moderate risk
3-in-1 TPN formula daily+overfill Bag
Lack of Assurance of Sterility
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