Class II · Moderate risk
B12 Hydroxocobalamin for Injection
Lack of Assurance of Sterility
Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/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
Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0112-30
Affected NDC
73198-0112-30
Compare with the code on your package — it is the most precise check available.
Drug: Hydroxocobalamin
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- NDC code
- 73198-0112-30
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0926-2022 · 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 completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydroxocobalamin recalls
See all
Class II · Moderate risk
Hydroxocobalamin-Pf- 1mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Hydroxocobalamin 25MG/ML
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Hydroxocobalamin B12
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
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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