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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92374

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 22, 2023
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
New England Life Care, Inc. dba Advanced Compounding Solutions

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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
Recall number
D-0778-2023
Initiated
May 22, 2023
Classification
Class III
Status
Terminated
Quantity
198

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.