Class II · Moderate risk
LX Bioboost Plus
Lack of Assurance of Sterility
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Super Potent and Failed Reconstitution Time
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
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate 9mg, Methionine 4mg, Edetate Disodium Dihydrate 2mg, Polysorbate mcg, Water for Injection, Multiple Dose Injection 5 mcg Vial, Rx Only, Olympia Compounding Pharmacy Compounded by: Olympia Pharmacy Conroy Rd., Ste. 155, Orlando, FL 32835, NDC 73198-0082-00 Revised Label: Sincalide Lyophilized powder for reconstitution, 5mcg per multi dose vial, Each ML contains: 16.7% Mannitol, 3% Arginine, 1.5% Lysine, 0.9% Potassium Phosphate, 0.4% Methionine, 0.2% Edetate Disodium Dihydrate, 0.004% Sodium Metabisulfate, 0.0005% Polysorbate. Water for injection. Rx only, Olympia Pharmaceuticals NDC 73198-0082-00
Affected NDC
73198-0082-00
Compare with the code on your package — it is the most precise check available.
Drug: Methionine
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- NDC code
- 73198-0082-00
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0724-2022 · 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 Methionine recalls
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Class II · Moderate risk
LL Bioboost Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Micc
Lack of assurance of sterility.
Class II · Moderate risk
Lipostat-Plus Methionine 25 mg/mL Inositol 50 mg/mL Choline…
Lack of assurance of sterility.
Class II · Moderate risk
Lipo-Mino-Mix Pyridoxine HCL
Lack of assurance of sterility.
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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