Recalls / Class III
Class IIID-0778-2023
Product
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25
- Affected lot / code info
- Lot # 20230323-728BF8, exp. 08/20/2023
Why it was recalled
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Recalling firm
- Firm
- New England Life Care, Inc. dba Advanced Compounding Solutions
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 4 Constitution Way Ste L, N/A, Woburn, Massachusetts 01801-1042
Distribution
- Quantity
- 198
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2023-05-22
- FDA classified
- 2023-06-01
- Posted by FDA
- 2023-06-07
- Terminated
- 2023-07-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0778-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.