Tri-Coast Pharmacy Recalls Sermorelin GT Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 920 vials of compounded Sermorelin GT nationwide due to a lack of assurance of sterility.
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 involves a lack of assurance of sterility in a drug product, which poses a risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Tri-Coast Pharmacy is voluntarily recalling 920 vials of Sermorelin GT (Sermorelin Acetate 15 mg/GHRP-2 5.4 mg/Theanine (L) 75 mg). The recall is being conducted because of a lack of assurance of sterility in the compounded products.
The affected products were compounded between May 17, 2016, and November 17, 2016, and were distributed nationwide. The recall includes specific lot codes with expiration dates ranging from December 12, 2016, to February 28, 2017.
Consumers and healthcare providers should stop using the recalled products and contact Tri-Coast Pharmacy or their healthcare provider for further instructions.
The recalled product
- Product
- Sermorelin GT (Sermorelin Acetate 15 mg/GHRP-2 5.4 mg/Theanine (L) 75 mg). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 920
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 (4)
- 07252016C (01/21/2017)
- 08262016C (02/22/2017)
- 10192016A (02/28/2017)
- 10242016B (02/28/2017).
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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