CLASS II Drug recall · Reported 14 Jun 2023 · FDA Enforcement Report
Ascorbic Acid Preserved Injection Solution recalled
Empower Clinic Services is recalling Ascorbic Acid Preserved Injection Solution, 500 mg/mL Sterile Multiple-Dose Vial, distributed nationwide in the US. The recall was initiated on 12 May 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0865-2023
- FDA event ID
- 92367
- Recalling firm
- Empower Clinic Services, Houston, TX
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 12 May 2023
- FDA classified
- 5 Jun 2023
- Reported
- 14 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 12 May 2023 | Recall initiated by company | |
| 5 Jun 2023 | Classified by FDA | +24 days |
| 14 Jun 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mislabeling: preservative free product labeled as preserved.
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Ascorbic Acid Preserved Injection Solution, 500 mg/mL Sterile Multiple-Dose Vial recalled?
Yes. Empower Clinic Services recalled Ascorbic Acid Preserved Injection Solution, 500 mg/mL Sterile Multiple-Dose Vial on 12 May 2023. The recall is Class II and its status is Completed. Recall number D-0865-2023.
Why was it recalled?
Mislabeling: preservative free product labeled as preserved.
Which lots are affected?
Lot: 606775 BUD: 09/25/2023
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Empower Clinic Services
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone Cypionate Injection, 200 mg/mL, CIII recalled | Empower Clinic Services | Sterility | Nationwide |
| Drug | CLASS II | Empower Pharmacy, Estradiol Cypionate Injection recalled | Empower Clinic Services | Sterility | Nationwide |