FDA Recall D-0535-2023
Focus Health Group Inc · Knoxville, TN
Class III Ongoing 1155 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
Product
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
Reason for recall
Labeling; Incorrect NDC number on outer carton of product.
Recall record
- Recall number
D-0535-2023- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2023-03-16
- Classified by FDA Center
- 2023-04-13
- FDA published
- 2023-04-19
- Recalling firm
- Focus Health Group Inc
- Firm location
- Knoxville, TN
Drug identification
- Brand name(s)
- EPINEPHRINE PROFESSIONAL
- Generic name(s)
- EPINEPHRINE AND ISOPROPYL ALCOHOL
- Manufacturer(s)
- Focus Health Group
- NDC(s)
24357-011- Route(s)
- INTRAMUSCULAR, SUBCUTANEOUS
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.