CLASS III Drug recall · Reported 30 Mar 2022 · FDA Enforcement Report
Hydroxocobalamin B12 1mg/mL, Multi-Dose vial recalled
Olympia Compounding Pharmacy is recalling Hydroxocobalamin B12 1mg/mL, Multi-Dose vial, Each ML contains: 0.82% Sodium Chloride USP, distributed nationwide in the US. The recall was initiated on 8 Mar 2022 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0723-2022
- FDA event ID
- 89717
- Recalling firm
- Olympia Compounding Pharmacy, Orlando, FL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Mar 2022
- FDA classified
- 29 Mar 2022
- Reported
- 30 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Mar 2022 | Recall initiated by company | |
| 29 Mar 2022 | Classified by FDA | +21 days |
| 30 Mar 2022 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sub Potent
Product as listed by the FDA
Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodium Chloride USP, 0.9% Benzyl Alcohol NF, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals Conroy Rd., Ste. 155, Orlando, FL 32835 NDC 73198-0080-30
Where it was distributed
Nationwide in the USA including Puerto Rico.
Questions about this recall
Why was it recalled?
Sub Potent
Which lots are affected?
Lot: E47025 Exp. 5/21/22
Where was it sold?
Nationwide in the USA including Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 89717This product is part of a recall event; the main page for the event is Sermorelin Acetate Lyophilized powder for reconstitution recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sermorelin Acetate Lyophilized powder for reconstitution recalled | Olympia Compounding Pharmacy | Other | Nationwide | |
| CLASS II | Sincalide Lyophilized powder recalled by Olympia Compounding Pharmacy | Olympia Compounding Pharmacy | Other | Nationwide | |
| CLASS III | T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE recalled | Olympia Compounding Pharmacy | Undeclared Sulfites | Nationwide | |
| CLASS III | Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL recalled | Olympia Compounding Pharmacy | Undeclared Sulfites | Nationwide | |
| CLASS III | SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL recalled | Olympia Compounding Pharmacy | Undeclared Sulfites | Nationwide | |
| CLASS II | NAD+ Nicotinamide Adenine Dinucleotide recalled | Olympia Compounding Pharmacy | Other | Nationwide |
More recalls from Olympia Compounding Pharmacy
All 94| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sermorelin Acetate Lyophilized powder recalled | Olympia Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Lipo-Mino-Mix Pyridoxine HCL recalled by Olympia Compounding Pharmacy | Olympia Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Zinc Chloride (0.5 mg/mL), Multi-Dose vial recalled | Olympia Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | NAD+ Nicotinamide Adenine Dinucleotide recalled | Olympia Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate 200 mg/mL in Sesame Oil recalled | Olympia Compounding Pharmacy | Sterility | Nationwide |
Other Hydroxocobalamin B12 recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydroxocobalamin B12, 1 mg/mL Multi-Dose vial recalled | Olympia Compounding Pharmacy | Manufacturing (CGMP) Deviations | Nationwide |