MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalamin 330 mcg/mL, Packaged as a) Multi-Dos
Summary
The FDA issued a Class II for MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalam by Olympia Compounding Pharmacy dba Olympia Pharmacy. Reason: Lack of assurance of sterility..
Details
Source
Drug Recall
External ID
D-0937-2022
Action Date
2022-06-01
Status
Completed
Category
drug
Product Description
MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalamin 330 mcg/mL, Packaged as a) Multi-Dose 10 mL vial, NDC 73198-0052-10; b) Multi-Dose 30 mL vial, NDC 73198-0052-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Lot/Code Info: Lots: K41F17, K41B17, K41C17, K41E17 BUD: 5/17/2022
Quantity Affected: 5334 vials
Reason for Recall
Lack of assurance of sterility.
Distribution
Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-09
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 101 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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-0937-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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