May 2023 FDA Recall Drug by New England Life Care, Inc. Dba Advanced Compounding Solutions
D-0778-2023 - Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

This Class III drug recall was voluntarily initiated by New England Life Care, Inc. Dba Advanced Compounding Solutions on May 22, 2023 for the product Drug. The FDA reported the reason for recall as product mix up; product was compounded in 250 ml 5% dextrose instead of 250 ml 0.9% sodium chloride. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0778-2023

Reason for Recall
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Initiated
05-22-2023
Reported
06-07-2023
Quantity
198

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92374
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
New England Life Care, Inc. dba Advanced Compounding Solutions
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-25-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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