December 2022 FDA Recall Drug by Baycare Integrated Service Center, Llc /dba Baycare Central Pharmacy
D-0086-2023 - Labeling

This Class I drug recall was voluntarily initiated by Baycare Integrated Service Center, Llc /dba Baycare Central Pharmacy on December 1, 2022 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in BayCare Health System hospitals in FL and the recall is currently terminated.

Recall Number: D-0086-2023

Reason for Recall
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Initiated
12-01-2022
Reported
12-21-2022
Quantity
250 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91283
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
BayCare Health System hospitals in FL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-15-2024
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

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