FDA Recalls Non-Sterile Human Chorionic Gonadotropin Syringes
Complete Pharmacy and Medical Solutions LLC is recalling 1,890 syringes of Human Chorionic Gonadotropin (HCG) due to confirmed mold contamination.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Human Chorionic Gonadotropin (HCG), 125 IU, in 0.5 ml syringes. The product is intended for subcutaneous administration and is available by prescription only. The recall involves 1,890 syringes manufactured by Complete Pharmacy and Medical Solutions LLC, located in Miami Lakes, Florida.
The recall was initiated because an outside laboratory confirmed the presence of mold in the product at the 14-day culture stage. This indicates a failure of sterility, which poses a significant risk of serious adverse health consequences to patients who use the medication.
The affected product is identified by Lot # 2079ps5 and has an expiration date of 02/01/2016. The syringes were distributed throughout Florida. Patients who have received this medication should contact their healthcare provider for guidance on next steps and potential health risks.
The recalled product
- Product
- Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
- Manufacturer
- Complete Pharmacy and Medical Solutions LLC
- Category
- Drug — Injectable Medication
- Affected units
- 1,890
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 2079ps5
- Exp 02/01/2016
Distribution
Distributed in 1 state:
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