Why it was recalled
Defective Delivery System
Product description
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
Lot numbers, UPCs & expiration codes
Lot, expiry: Lot 150892, exp Oct 2022; Lot 153199, exp Feb 2023; Lot 156041, exp Apr 2023
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0372-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 27, 2021
- FDA report date
- Jan 19, 2022
- Quantity
- 11,868 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Padagis US LLC
Original FDA data
Every field from FDA enforcement report D-0372-2022, exactly as published.
Show all FDA fields
- City
- Minneapolis
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 89310
- Address
- 3940 Quebec Ave N
- Code information
- Lot, expiry: Lot 150892, exp Oct 2022; Lot 153199, exp Feb 2023; Lot 156041, exp Apr 2023
- Postal code
- 55427-1244
- Report date
- Jan 19, 2022
- Product type
- Drugs
- Recall number
- D-0372-2022
- Classification
- Class II
- Recalling firm
- Padagis US LLC
- Product quantity
- 11,868 bottles
- Termination date
- Sep 28, 2023
- Reason for recall
- Defective Delivery System
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Dec 27, 2021
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jan 13, 2022