Tri-Coast Pharmacy Recalls Sermorelin Forte Plus Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 2,116 vials of Sermorelin Forte Plus 27 mg because the products lack 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 injectable products, which poses a significant risk of infection or serious injury.
Plain-English summary
Tri-Coast Pharmacy is recalling 2,116 vials of Sermorelin Forte Plus 27 mg (Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg). The recall is due to a lack of assurance of sterility in the compounded products.
The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The products were distributed nationwide. Specific lot codes and expiration dates are listed in the recall documentation, including 05252016B, 06232016B, 07152016B, 08262016D, 08152016A, 08022016C, 09282016C, 10192016C, and 10252016B.
Consumers should check their medication for these lot codes and expiration dates. If the product matches the recalled items, they should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Sermorelin Forte Plus 27 mg (Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 2,116
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 (8)
- 06232016B (12/20/2016)
- 07152016B (01/11/2017)
- 08262016D (01/30/2017)
- 08152016A (01/30/2017)
- 08022016C (01/29/2017)
- 09282016C (03/27/2017)
- 10192016C (04/17/2016)
- 10252016B (04/23/2017).
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.
See all 80 products in this recall →Related recalls
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