Recalls / Class II
Class IID-0372-2022
Product
Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeruham, Israel; Distributed by Perrigo, Allegan, MI 49010, NDC 45802-210-02
- Brand name
- Nitroglycerin Lingual
- Generic name
- Nitroglycerin
- Active ingredient
- Nitroglycerin
- Route
- Oral
- NDC
- 45802-210
- FDA application
- ANDA091496
- Affected lot / code info
- Lot, expiry: Lot 150892, exp Oct 2022; Lot 153199, exp Feb 2023; Lot 156041, exp Apr 2023
Why it was recalled
Defective Delivery System
Recalling firm
- Firm
- Padagis US LLC
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 3940 Quebec Ave N, N/A, Minneapolis, Minnesota 55427-1244
Distribution
- Quantity
- 11,868 bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2021-12-27
- FDA classified
- 2022-01-13
- Posted by FDA
- 2022-01-19
- Terminated
- 2023-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0372-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.