PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride recall: CGMP Deviations
PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;
Why was PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 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 # 20230524-6FBB77, Exp 21OCT2023
- Product
- PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;
- Recalling firm
- New England Life Care, Inc. dba Advanced Compounding Solutions
- Quantity
- 82 Bags
- Distribution
- Nationwide in the USA
- Recall date
- July 26, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)