The Recall Desk
SevereFDA (Drugs)·D-0585-2017·Announced 2017-03-22

Synergy Rx Recalls Human Chorionic Gonadotropin Tablets Due to Sterility Concerns

Synergy Rx is recalling Human Chorionic Gonadotropin tablets 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 the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in a drug) are rated as Severe.

Plain-English summary

Synergy Rx is recalling Human Chorionic Gonadotropin tablets in 300 IU and 500 IU strengths. The recall is due to a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.

The affected product is prescription-only and was distributed nationwide within the United States. The recall covers all lots of the product.

Consumers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
HUMAN CHORIONIC GONADOTROPIN in 300IU and 500 IU TABLETS, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Manufacturer
Synergy Rx

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.

See all 81 products in this recall →