Sermorelin Acetate Vials Recalled for Lack of Sterility Assurance
KRS Global Biotechnology is recalling Sermorelin Acetate vials due to a lack of assurance of sterility. The recall covers 341 vials distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. 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, which corresponds to a Severe rating under the rubric. The hazard involves a lack of sterility assurance for a subcutaneous injection, posing a significant risk of infection.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only (NDC 3321673588). The recall is being conducted because of a lack of assurance of sterility in the product.
The recall involves 341 vials of the medication. These products were distributed nationwide. The recall applies to all lots remaining within their expiry dates.
Consumers and healthcare providers should stop using the affected Sermorelin Acetate vials and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Affected units
- 341
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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