Recalls / Class II
Class IID-0927-2023
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;
- Affected lot / code info
- Lot # 20230524-6FBB77, Exp 21OCT2023
Why it was recalled
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Recalling firm
- Firm
- New England Life Care, Inc. dba Advanced Compounding Solutions
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4 Constitution Way Ste L, N/A, Woburn, Massachusetts 01801-1042
Distribution
- Quantity
- 82 Bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-07-10
- FDA classified
- 2023-07-19
- Posted by FDA
- 2023-07-26
- Terminated
- 2023-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0927-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.