B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Summary
The FDA issued a Class II for B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road by Valgene Incorporated dba Cape Drugs. Reason: Lack of Processing Controls.
Details
Source
Drug Recall
External ID
D-0284-2022
Action Date
2021-12-22
Status
Terminated
Category
drug
Product Description
B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Lot/Code Info: Lot# 190036, BUD 12/27/2021
Quantity Affected: 12 vials
Reason for Recall
Lack of Processing Controls
Distribution
Maryland Only
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-03
Company
Annapolis, MD
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 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Valgene Incorporated dba Cape Drugs 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 (Valgene Incorporated dba Cape Drugs) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Valgene Incorporated dba Cape Drugs have FDA actions?
Valgene Incorporated dba Cape Drugs 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-0284-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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