Why it was recalled
Lack of Assurance of Sterility
Product description
Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-0589-30
Lot numbers, UPCs & expiration codes
Lot: 091721589 BUD: 03/16/2022
Where it was sold
United States
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-0261-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 17, 2021
- FDA report date
- Dec 8, 2021
- Quantity
- 896 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ASP CARES
Original FDA data
Every field from FDA enforcement report D-0261-2022, exactly as published.
Show all FDA fields
- City
- San Antonio
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 89076
- Address
- 2414 Babcock Rd Ste 106
- Code information
- Lot: 091721589 BUD: 03/16/2022
- Postal code
- 78229-4870
- Report date
- Dec 8, 2021
- Product type
- Drugs
- Recall number
- D-0261-2022
- Classification
- Class II
- Recalling firm
- ASP CARES
- Product quantity
- 896 vials
- Termination date
- Dec 2, 2022
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-0589-30
- Distribution pattern
- United States
- Recall initiation date
- Nov 17, 2021
- Initial firm notification
- Letter
- Center classification date
- Nov 26, 2021