Why it was recalled
Lack of Assurance of Sterility
Product description
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-284-25
Lot numbers, UPCs & expiration codes
Lot #: AC-016647, Exp. Date 06/28/2023
Where it was sold
Missouri only
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-0638-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 2, 2023
- FDA report date
- May 24, 2023
- Quantity
- 1113 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apollo Care, LLC
Original FDA data
Every field from FDA enforcement report D-0638-2023, exactly as published.
Show all FDA fields
- City
- Columbia
- State
- MO
- Status
- Ongoing
- Country
- United States
- Event ID
- 92348
- Address
- 3801 Mojave Ct Ste 101
- Code information
- Lot #: AC-016647, Exp. Date 06/28/2023
- Postal code
- 65202-4042
- Report date
- May 24, 2023
- Product type
- Drugs
- Recall number
- D-0638-2023
- Classification
- Class II
- Recalling firm
- Apollo Care, LLC
- Product quantity
- 1113 bags
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-284-25
- Distribution pattern
- Missouri only
- Recall initiation date
- May 2, 2023
- Initial firm notification
- Letter
- Center classification date
- May 18, 2023