Drug Enforcement D-0865-2023

Mislabeling: preservative free product labeled as preserved.

Status

Completed

Classification

Class II

Report Date

June 14, 2023

Termination Date

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Product Information

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
Product quantity
504 vials
Reason for recall
Mislabeling: preservative free product labeled as preserved.
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Distributed Nationwide in the USA

Location & Firm

Recalling firm
Empower Clinic Services LLC dba Empower Pharmacy
Address
5980 W Sam Houston Pkwy N Ste 300

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0865-2023
Event ID
92367
Recall initiation date
May 12, 2023
Center classification date
June 5, 2023
Code info
Lot: 606775 BUD: 09/25/2023
More code info
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