Class II · Moderate risk
Sermorelin Lyophilized powder for reconstitution
Lack of Assurance of Sterility
Sermorelin Acetate Lyophilized powder for reconstitution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Sub Potent
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0059-00
Affected NDC
73198-0059-00
Compare with the code on your package — it is the most precise check available.
Drug: Sermorelin
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- NDC code
- 73198-0059-00
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0718-2022 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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 Olympia Compounding Pharmacy dba Olympia Pharmacy
All 2022 recalls
Class II · Moderate risk
Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine…
Lack of assurance of sterility.
Class II · Moderate risk
QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60…
Lack of assurance of sterility.
Class II · Moderate risk
Pyridoxine HCL 100 mg/mL
Lack of assurance of sterility.
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