Tri-Coast Pharmacy Recalls Sermorelin Forte Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 188 vials of Sermorelin Forte 12 mg because the agency could not ensure the sterile products were free from contamination.
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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a drug with a sterility defect (which carries a risk of infection) is categorized as Severe (Score 4), particularly given the structural nature of the defect in a sterile injectable product.
Plain-English summary
Tri-Coast Pharmacy is voluntarily recalling 188 vials of Sermorelin Forte 12 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg). The recall is being conducted because the U.S. Food and Drug Administration (FDA) determined there was 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 products were distributed nationwide. Specific lot codes identified in the recall include 06152016C (expiration date 12/12/2016) and 10242016C (expiration date 04/22/2017).
Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the product if it matches the recalled description. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Sermorelin Forte 12 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Sterile Drug
- Affected units
- 188
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)
- 10242016C (04/22/2017).
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.
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