Drug Enforcement D-0778-2023

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

Status

Terminated

Classification

Class III

Report Date

June 7, 2023

Termination Date

July 25, 2023

Product Information

Product description
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
Product quantity
198
Reason for recall
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide in the USA.

Location & Firm

Recalling firm
New England Life Care, Inc. dba Advanced Compounding Solutions
Address
4 Constitution Way Ste L, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0778-2023
Event ID
92374
Recall initiation date
May 22, 2023
Center classification date
June 1, 2023
Code info
Lot # 20230323-728BF8, exp. 08/20/2023
More code info
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