Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC 342806263013
Lot numbers, UPCs & expiration codes
Lot #: P0910-017, Exp. 05/2019
Where it was sold
NY only
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-0107-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 13, 2017
- FDA report date
- Dec 13, 2017
- Quantity
- 1264 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Elite Laboratories Inc.
Original FDA data
Every field from FDA enforcement report D-0107-2018, exactly as published.
Show all FDA fields
- City
- Northvale
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78502
- Address
- 165 Ludlow Ave
- Code information
- Lot #: P0910-017, Exp. 05/2019
- Postal code
- 07647-2305
- Report date
- Dec 13, 2017
- Product type
- Drugs
- Recall number
- D-0107-2018
- Classification
- Class III
- Recalling firm
- Elite Laboratories Inc.
- Product quantity
- 1264 bottles
- Termination date
- Mar 15, 2019
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC 342806263013
- Distribution pattern
- NY only
- Recall initiation date
- Nov 13, 2017
- Initial firm notification
- Center classification date
- Dec 5, 2017