KRS Global Biotechnology Recalls Sermorelin Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling Sermorelin vials because the company cannot guarantee the product is sterile. Consumers should stop using the medication and contact their healthcare provider.
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 FDA classified this recall as Class II, which corresponds to a 'Severe' rating under the provided rubric, as it may cause temporary or medically reversible adverse health consequences.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 246 vials of Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized. The recall was initiated because the manufacturer lacks assurance of the product's sterility. The affected product is prescription-only and was distributed nationwide.
The recall includes all lots of the product that remain within their expiration dates. The specific NDC number for the recalled product is 3321673589. 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.
Consumers who have this product should stop using it immediately. They should contact their healthcare provider for further instructions on how to proceed. The recall is being handled by KRS Global Biotechnology, Inc.
The recalled product
- Product
- Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 246
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)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 80 recalled by KRS Global Biotechnology, Inc 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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