Tri-Coast Pharmacy Recalls Sermorelin Acetate Due to Sterility Concerns
Tri-Coast Pharmacy is recalling Sermorelin Acetate 9 mg vials because there is a lack of assurance of sterility. The recall covers products compounded between May and November 2016.
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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterile products where sterility assurance is compromised, posing a risk of serious adverse health consequences.
Plain-English summary
Tri-Coast Pharmacy is recalling Sermorelin Acetate 9 mg vials due to a lack of assurance of sterility. The recall includes 54 vials of sterile products compounded by the pharmacy between May 17, 2016, and November 17, 2016. The specific lot code identified in the notice is 08022016B, with an expiration date of January 29, 2017.
The distribution of these products was nationwide. The recall is classified as Class II by the U.S. Food and Drug Administration. This classification indicates that the product could temporarily cause or present a slight probability of serious adverse health consequences.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Sermorelin Acetate 9 mg. Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Hazard
- Affected units
- 54
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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