Tri-Coast Pharmacy Recalls Sermorelin Acetate Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 91 vials of Sermorelin Acetate 15 mg compounded between May and November 2016 because the agency 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a compounded drug, which carries a significant risk of infection or serious injury.
Plain-English summary
Tri-Coast Pharmacy is recalling 91 vials of Sermorelin Acetate 15 mg. The recall covers all sterile products compounded by the pharmacy between May 17, 2016, and November 17, 2016. The specific lot code identified in the recall is 08152016B, with an expiration date of February 11, 2017.
The recall was initiated due to a lack of assurance of sterility. This means there is a potential risk that the medication may not be free from microorganisms, which could pose a health risk to patients using the product.
The affected products were distributed nationwide. Patients who have received Sermorelin Acetate 15 mg from Tri-Coast Pharmacy during the specified period should contact their healthcare provider or the pharmacy for further instructions on how to proceed.
The recalled product
- Product
- Sermorelin Acetate 15 mg. Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Affected units
- 91
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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