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
Reported: June 2, 2021 Initiated: March 15, 2021 #D-0473-2021
Product Description
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
Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Details
- Recalling Firm
- Cardinal Health Inc.
- Units Affected
- 11189 plungers
- Distribution
- FL, GA, SC
- Location
- Dublin, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cardinal Health Inc.. Units affected: 11189 plungers.
Why was this product recalled? ▼
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0473-2021.
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