Class II · Moderate risk
Sermorelin Lyophilized powder for reconstitution
Lack of Assurance of Sterility
Sermorelin Acetate
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00; b) 9 mg NDC 73198-0059-00, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.
Affected NDCs
73198-0059-00
73198-0060-00
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
- 73198-0060-00
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0797-2022 · 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.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.