The Recall Desk
SevereFDA (Drugs)·D-0290-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Sermorelin Forte Due to Sterility Concerns

Tri-Coast Pharmacy is recalling Sermorelin Forte 6 mg vials because the agency could not ensure the products were sterile.

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 hazard involves a lack of assurance of sterility in a sterile injectable product, which poses a significant risk of infection.

Plain-English summary

Tri-Coast Pharmacy is recalling Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/GHRP-6 3 mg) vials. The recall is being conducted because there is a lack of assurance of sterility for the affected products.

The recall includes all sterile products compounded by Tri-Coast Pharmacy between May 17, 2016, and November 17, 2016. The known lot code is 10192016A, with an expiration date of April 17, 2017. The affected products were distributed nationwide.

Consumers who have these products should stop using them and contact Tri-Coast Pharmacy for further instructions or a refund.

The recalled product

Product
Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/GHRP-6 3 mg). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Affected units
7

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 80 recalled by Tri-Coast Pharmacy 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 80 products in this recall →