KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns
KRS Global Biotechnology is recalling 152 cartridges of Sermorelin Acetate 9 mg/3 mL nationwide due to a lack of assurance of sterility.
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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls with potential for serious injury (such as sterility failures in injectable drugs) are classified as Severe (Score 4), as they are not Class I but involve significant health risks.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 152 cartridges of Sermorelin Acetate 9 mg/3 mL (3 mg/mL), prescription only. The product was distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify which lot numbers are affected, but notes that all lots remaining within expiry are included. No specific dates of distribution or manufacturing are provided in the source.
Consumers with this product should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal. The source does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable Prescription
- Affected units
- 152
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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