Synergy Rx Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns
Synergy Rx is recalling 1,809 vials of Human Chorionic Gonadotropin (HCG) because the product lacks assurance of sterility and has CGMP deviations.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Synergy Rx is recalling 1,809 vials of Human Chorionic Gonadotropin (HCG) in 5,000 units/vial and 11,000 units/vial strengths. The recall covers all lots of the prescription-only medication, which was distributed nationwide within the United States.
The recall was initiated due to a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations. These issues indicate that the manufacturing process did not meet required standards for ensuring the product is sterile.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The product is prescription-only, so patients should consult their prescriber regarding alternative treatments or next steps.
The recalled product
- Product
- Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 1,809
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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 81 recalled by Synergy Rx under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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