Drug Enforcement D-0535-2023

Labeling; Incorrect NDC number on outer carton of product.

Status

Ongoing

Classification

Class III

Report Date

April 19, 2023

Termination Date

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Product Information

Product description
Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health Group, 5802 Kingston Pike, Knoxville, TN 37919. Incorrect NDC (kit): 24357-011-13
Product quantity
246 kits
Reason for recall
Labeling; Incorrect NDC number on outer carton of product.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Focus Health Group Inc
Address
5802 Kingston Pike, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0535-2023
Event ID
91911
Recall initiation date
March 16, 2023
Center classification date
April 13, 2023
Code info
Lot numbers: 57943EMS, exp 5/31/2023; 56276EMS, exp 4/30/2024
More code info
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