Nitroglycerin Lingual Spray Recalled for Defective Delivery System
Padagis US LLC is recalling Nitroglycerin Lingual Spray due to a defective delivery system that may prevent proper medication administration. The recall affects 11,868 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a cardiac emergency medication where a defective delivery system prevents proper drug administration, creating a significant risk of harm to patients dependent on this medication for angina management. No illnesses or injuries are reported in the source text, but the functional defect in a critical-use drug poses inherent patient safety risk.
Plain-English summary
Padagis US LLC is recalling Nitroglycerin Lingual Spray, 400 mcg per spray, due to a defective delivery system. The affected product consists of 11,868 bottles with the following lot numbers and expiration dates: Lot 150892 (exp. Oct 2022), Lot 153199 (exp. Feb 2023), and Lot 156041 (exp. Apr 2023).
The recalled product was manufactured by Perrigo in Yeruham, Israel, and distributed by Perrigo in Allegan, Michigan. Distribution was nationwide throughout the USA. The defective delivery system in these bottles may prevent patients from receiving the proper dose of medication.
Patients using the affected product should contact their healthcare provider or pharmacist for a replacement. This is a prescription-only medication used to treat angina, and proper delivery is critical for patient safety.
The recalled product
- Product
- NITROGLYCERIN LINGUAL (NITROGLYCERIN)
- Brand
- NITROGLYCERIN LINGUAL
- Manufacturer
- Padagis US LLC
- Category
- Drug — Cardiovascular / Nitrate
- Affected units
- 11,868
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot
- expiry: Lot 150892
- exp Oct 2022
- Lot 153199
- exp Feb 2023
- Lot 156041
- exp Apr 2023
Distribution
Distributed nationwide across the United States.
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