Drug 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
D-0473-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11189 plungers
- Official record key
drug-enforcement:D-0473-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 201701
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations