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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91197

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

Open FDA event record

Event summary

Timeline bucket
November 28, 2022
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Exela Pharma Sciences 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

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.

D-0079-2023
Recall number
D-0079-2023
Initiated
November 28, 2022
Classification
Class I
Status
Terminated
Recalling firm
Exela Pharma Sciences LLC
Quantity
489,600 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Code information

Lots: P0001178 Exp. 05/2023; P0001298, P0001301, P0001313, P0001314, P0001317 Exp. 08/2023; P0001330, P0001464 Exp. 09/2023; P0001442 Exp. 11/2023; P0001467, P0001472, P0001486, P0001532 Exp. 12/2023.

Distribution pattern

Nationwide within the United States

drug · product 2 of 2

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.

D-0080-2023
Recall number
D-0080-2023
Initiated
November 28, 2022
Classification
Class I
Status
Terminated
Recalling firm
Exela Pharma Sciences LLC
Quantity
37,320 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Code information

Lot: P0001490 Exp. 12/2023

Distribution pattern

Nationwide within the United States