Why it was recalled
Lack of Assurance of Sterility
Product description
Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.
Lot numbers, UPCs & expiration codes
Product lot number: 609763 Beyond Use Date: 04/18/2025
Where it was sold
Nationwide
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-0663-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 5, 2024
- FDA report date
- Oct 2, 2024
- Quantity
- 450
- Recalling firm
- Empower Pharmacy
Original FDA data
Every field from FDA enforcement report D-0663-2024, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 95304
- Address
- 5980 W Sam Houston Pkwy N Ste 300
- Code information
- Product lot number: 609763 Beyond Use Date: 04/18/2025
- Postal code
- 77041-5254
- Report date
- Oct 2, 2024
- Product type
- Drugs
- Recall number
- D-0663-2024
- Classification
- Class II
- Recalling firm
- Empower Pharmacy
- Product quantity
- 450
- Termination date
- Feb 14, 2025
- Reason for recall
- Lack of Assurance of Sterility
- Product description
- Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 5, 2024
- Initial firm notification
- Letter
- Center classification date
- Sep 20, 2024