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Class II: temporary or reversible health riskCompleted

Empower Clinic Services LLC dba Empower Pharmacy Ascorbic Acid Preserved Injection Solution Recall

ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial…

Empower Clinic Services LLC dba Empower Pharmacy · Houston, TX

Risk level
Class II
Reported by FDA
Jun 14, 2023
Recall ID
D-0865-2023
Check your lot numberHow we source this data

Summary

Empower Clinic Services LLC dba Empower Pharmacy recalled Ascorbic Acid Preserved Injection Solution starting May 12, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0865-2023 on Jun 14, 2023. Reason: Mislabeling: preservative free product labeled as preserved. Status: Completed.

Why it was recalled

Mislabeling: preservative free product labeled as preserved.

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 numbers, UPCs & expiration codes

Lot: 606775 BUD: 09/25/2023

Where it was sold

Distributed Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0865-2023
Classification
Class II
Status
Completed
Recall initiated
May 12, 2023
FDA report date
Jun 14, 2023
Quantity
504 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Empower Clinic Services LLC dba Empower Pharmacy

Original FDA data

Every field from FDA enforcement report D-0865-2023, exactly as published.

Show all FDA fields
City
Houston
State
TX
Status
Completed
Country
United States
Event ID
92367
Address
5980 W Sam Houston Pkwy N Ste 300
Code information
Lot: 606775 BUD: 09/25/2023
Postal code
77041-5251
Report date
Jun 14, 2023
Product type
Drugs
Recall number
D-0865-2023
Classification
Class II
Recalling firm
Empower Clinic Services LLC dba Empower Pharmacy
Product quantity
504 vials
Reason for recall
Mislabeling: preservative free product labeled as preserved.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Distributed Nationwide in the USA
Recall initiation date
May 12, 2023
Initial firm notification
E-Mail
Center classification date
Jun 5, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0865-2023, published Jun 14, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

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