Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodium Chloride USP, 0.9% Benzyl Alcohol NF,
Summary
The FDA issued a Class III for Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodi by Olympia Compounding Pharmacy dba Olympia Pharmacy. Reason: Sub Potent.
Details
Source
Drug Recall
External ID
D-0723-2022
Action Date
2022-03-30
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot: E47025 Exp. 5/21/22
Quantity Affected: 1613 vials
Reason for Recall
Sub Potent
Distribution
Nationwide in the USA including Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-08
Company
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 78 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Olympia Compounding Pharmacy dba Olympia Pharmacy has 94 FDA actions in our database, including 94 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympia Compounding Pharmacy dba Olympia Pharmacy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympia Compounding Pharmacy dba Olympia Pharmacy have FDA actions?
Olympia Compounding Pharmacy dba Olympia Pharmacy has 94 FDA actions in our database, including 94 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0723-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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