The Recall Desk
SevereFDA (Drugs)·D-1463-2016·Announced 2016-08-31

Talon Compounding Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns

Talon Compounding Pharmacy is recalling Sermorelin and Sermorelin/GHRP-2 injections because the FDA cannot assure the products are 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 rubric specifies that FDA Class II recalls with potential for serious health consequences, such as lack of sterility assurance which can lead to infection, are classified as Severe (Score 4).

Plain-English summary

Talon Compounding Pharmacy, located in San Antonio, Texas, is recalling 500 vials of Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials. The recall was initiated because the FDA cannot assure the sterility of these compounded prescription drugs.

The affected products were distributed nationwide. The recall covers multiple lot numbers, including those beginning with 01082016, 01202016, 02012016, and others listed in the official notice. The agency has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

Consumers who have these specific vials should stop using them and contact their healthcare provider or the pharmacy for further instructions. The recall is limited to the specific lot numbers identified in the FDA notice.

The recalled product

Product
Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247
Affected units
500

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Talon Compounding 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 2 products in this recall →

Same manufacturer · Talon Compounding Pharmacy

See all →