MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalamin 330 mcg/mL, Pa...
FDA Recall #D-0937-2022 — Class II — May 9, 2022
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
Reason for Recall
Lack of assurance of sterility.
Recalling Firm
Olympia Compounding Pharmacy dba Olympia Pharmacy — Orlando, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5334 vials
Distribution
Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Code Information
Lots: K41F17, K41B17, K41C17, K41E17 BUD: 5/17/2022
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated