May 2023 FDA Recall Drug by Empower Clinic Services Llc Dba Empower Pharmacy
D-0865-2023 - Mislabeling

This Class II drug recall was voluntarily initiated by Empower Clinic Services Llc Dba Empower Pharmacy on May 12, 2023 for the product Drug. The FDA reported the reason for recall as mislabeling. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0865-2023

Reason for Recall
Mislabeling: preservative free product labeled as preserved.
Initiated
05-12-2023
Reported
06-14-2023
Quantity
504 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92367
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Empower Clinic Services LLC dba Empower Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lot: 606775 BUD: 09/25/2023