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Recall Observatory FDA recall evidence

Drug 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

D-0778-2023

May 22, 2023

Class III

Product summary

Firm
New England Life Care, Inc. dba Advanced Compounding Solutions
Event
Event 92374
Status
Terminated
Classification
Class III
Quantity
198
Official record key
drug-enforcement:D-0778-2023

Official wording

Reason: Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

Code information: Lot # 20230323-728BF8, exp. 08/20/2023

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride