Empower Pharmacy Ascorbic Acid Injection Mislabeled as Preserved
Empower Pharmacy is recalling Ascorbic Acid 500 mg/mL injection solution because vials labeled as preserved are actually preservative-free. The 504 affected vials were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a mislabeling of a sterile injectable product where the preservative status is misrepresented, creating a risk of improper use. FDA Class II designation confirms this is a serious defect. With no reported illnesses or injuries, this recall meets the 'High' category as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Empower Pharmacy is recalling ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL in 30 mL sterile multiple-dose vials (NDC 72627-2405-1, Lot 606775, beyond-use date 09/25/2023). The product is mislabeled: vials are labeled as preserved when the product is actually preservative-free.
Preservative-free injectable solutions require different handling and storage than preserved formulations. Healthcare providers relying on the label may unknowingly use the product inappropriately, potentially affecting treatment efficacy and patient safety. The recall affects 504 vials distributed nationwide.
Healthcare facilities and providers who received this product should stop use immediately and contact the recalling firm, Empower Clinic Services LLC (dba Empower Pharmacy), at 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041.
The recalled product
- 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
- Manufacturer
- Empower Clinic Services LLC dba Empower Pharmacy
- Category
- Drug — Injectable / Compounded
- Hazard
- mislabeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 606775 BUD: 09/25/2023
Distribution
Distributed nationwide across the United States.
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