Why it was recalled
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Product description
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;
Lot numbers, UPCs & expiration codes
Lot # 20230524-0113AB, Exp 22AUG2023
Where it was sold
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-0929-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 10, 2023
- FDA report date
- Jul 26, 2023
- Quantity
- 209 Bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- New England Life Care, Inc. dba Advanced Compounding Solutions
Original FDA data
Every field from FDA enforcement report D-0929-2023, exactly as published.
Show all FDA fields
- City
- Woburn
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 92690
- Address
- 4 Constitution Way Ste L
- Code information
- Lot # 20230524-0113AB, Exp 22AUG2023
- Postal code
- 01801-1042
- Report date
- Jul 26, 2023
- Product type
- Drugs
- Recall number
- D-0929-2023
- Classification
- Class II
- Recalling firm
- New England Life Care, Inc. dba Advanced Compounding Solutions
- Product quantity
- 209 Bags
- Termination date
- Dec 4, 2023
- Reason for recall
- CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 10, 2023
- Initial firm notification
- Letter
- Center classification date
- Jul 19, 2023