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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88436

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

Open FDA event record

Event summary

Timeline bucket
August 10, 2021
Product types
Drug
Classifications
Class I and Class II
Statuses
Terminated
Recalling firm wording
SterRx, 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

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01

D-0767-2021
Recall number
D-0767-2021
Initiated
August 10, 2021
Classification
Class I
Status
Terminated
Recalling firm
SterRx, LLC
Quantity
1098 bags

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility: firm's third party lab confirmed microbial contamination.

Code information

Lot Number: BUP, exp. date 03/23/22

Distribution pattern

Nationwide in the US

drug · product 2 of 2

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903

D-0768-2021
Recall number
D-0768-2021
Initiated
August 10, 2021
Classification
Class II
Status
Terminated
Recalling firm
SterRx, LLC
Quantity
3378 bags

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot Numbers: BTW, exp. date 03/08/22 BUI, exp. date 03/16/22

Distribution pattern

Nationwide in the US