Recalls / Class II
Class IID-0473-2021
Product
Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of naloxone HCl in 0.1 mL of nasal spray. 0.1 mL intranasal spray per unit For use in the nose only Rx only NDC 69547-353-02 Distributed by Adapt Pharma, Inc. Radnor, PA 19087 USA
- Brand name
- Narcan
- Generic name
- Naloxone Hydrochloride
- Active ingredient
- Naloxone Hydrochloride
- Route
- Nasal
- NDC
- 69547-353
- FDA application
- NDA208411
- Affected lot / code info
- 201701
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Emergent Devices Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 11189 plungers
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0473-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.