ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower
Summary
The FDA issued a Class II for ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Do by Empower Clinic Services LLC dba Empower Pharmacy. Reason: Mislabeling: preservative free product labeled as preserved..
Details
Source
Drug Recall
External ID
D-0865-2023
Action Date
2023-06-14
Status
Completed
Category
drug
Product Description
ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1
Lot/Code Info: Lot: 606775 BUD: 09/25/2023
Quantity Affected: 504 vials
Reason for Recall
Mislabeling: preservative free product labeled as preserved.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-12
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 122 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Empower Clinic Services LLC dba Empower Pharmacy 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 (Empower Clinic Services LLC dba Empower Pharmacy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Empower Clinic Services LLC dba Empower Pharmacy have FDA actions?
Empower Clinic Services LLC dba Empower Pharmacy 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-0865-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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