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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88731

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 17, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
IntegraDose Compounding Services LLC

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

2 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 2

ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1

D-0896-2021
Recall number
D-0896-2021
Initiated
September 17, 2021
Classification
Class II
Status
Terminated
Quantity
2,614 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot, expiry: Lot 20210803CEF-1, exp 09/17/2021; Lot 20210805CEF-3, 09/19/2021; Lots 20210806CEF-1, 20210806CEF-2, exp 09/20/2021; Lots 20210809CEF-1, 20210809CEF-2, exp 09/23/2021; Lot 20210810CEF-1, exp 09/24/2021; Lot 20210811CEF-1, exp 09/25/2021; Lot 20210812CEF-1, exp 09/26/2021

Distribution pattern

NH, MA, MN

drug · product 2 of 2

ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1

D-0897-2021
Recall number
D-0897-2021
Initiated
September 17, 2021
Classification
Class II
Status
Terminated
Quantity
589 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot, expiry: 20210722CEF-2, exp 09/20/2021; 20210728CEF-1, exp 09/26/2021

Distribution pattern

NH, MA, MN