Vancomycin HCl recall: CGMP Deviations
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;
Why was Vancomycin HCl recalled?
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 20230524-0113AB, Exp 22AUG2023
- Product
- 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;
- Recalling firm
- New England Life Care, Inc. dba Advanced Compounding Solutions
- Quantity
- 209 Bags
- Distribution
- Nationwide in the USA
- Recall date
- July 26, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)