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FDAJuly 10, 2023drug

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;

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

What to do

FDA enforcement status: Terminated

Brands named

new england life care inc dba advanced compounding solutions

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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