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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91283

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

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Event summary

Timeline bucket
December 01, 2022
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy

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

Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637.

D-0086-2023
Recall number
D-0086-2023
Initiated
December 01, 2022
Classification
Class I
Status
Terminated
Quantity
250 syringes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL

Code information

Lot: IOHE2.420221128, Exp. 12/7/2022

Distribution pattern

BayCare Health System hospitals in FL