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 la
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Summary
The FDA issued a Class I for Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syring by BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy. Reason: Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL.
Details
Source
Drug Recall
External ID
D-0086-2023
Action Date
2022-12-21
Status
Terminated
Category
drug
Product Description
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.
Lot/Code Info: Lot: IOHE2.420221128, Exp. 12/7/2022
Quantity Affected: 250 syringes
Reason for Recall
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Distribution
BayCare Health System hospitals in FL
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-01
Company
Temple Terrace, FL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 29 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy have FDA actions?
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0086-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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