Class II · Moderate risk
Sermorelin Lyophilized powder for reconstitution
Lack of Assurance of Sterility
Sermorelin/Glycine 2000mcg/5mg/mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding
Drug: Sermorelin
- Recalling firm
- TMC Acquisition LLC dba Tailor Made Compounding
- Origin
- KY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1227-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Sermorelin recalls
See all
Class II · Moderate risk
Sermorelin Acetate 1 MG/ML Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial
Lack of assurance of sterility.
Class II · Moderate risk
Sermorelin Acetate 1 mg/mL
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Ipamorelin Acetate/Sermorelin Acetate
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Other recalls by TMC Acquisition LLC dba Tailor Made Compounding
All 2022 recalls
Class II · Moderate risk
Glutathione 200mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin D3 50
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin B-Complex Preservative Free
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin B-Complex
Lack of Assurance of Sterility
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