Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW IN
Summary
The FDA issued a Class II for Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) by McGuff Compounding Pharmacy Services, Inc.. Reason: Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy..
Details
Source
Drug Recall
External ID
D-0267-2023
Action Date
2023-02-22
Status
Terminated
Category
drug
Product Description
Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 30 mL Sterile Multiple Use Vial, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704.
Lot/Code Info: Lot: 22K1661, initial BUD: 12/18/2022, extended BUD: 1/27/2023; 22J2401, BUD: 12/19/2022.
Quantity Affected: 255 vials
Reason for Recall
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-08
Company
Santa Ana, CA
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 73 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
McGuff Compounding Pharmacy Services, Inc. has 2 FDA actions in our database, including 2 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 (McGuff Compounding Pharmacy Services, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does McGuff Compounding Pharmacy Services, Inc. have FDA actions?
McGuff Compounding Pharmacy Services, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0267-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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