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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Manufacturer
- Talon Compounding Pharmacy
- Category
- Drug — Compounded Prescription
- Hazard
- 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.
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