Isradapine Capsules USP 2.5 mg recall: Impurity Out of Spec
Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC…
Why was Isradapine Capsules USP 2.5 mg recalled?
Failed Impurities/Degradation Specifications
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: P0910-017, Exp. 05/2019
- Product
- Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC…
- Recalling firm
- Elite Laboratories Inc.
- Quantity
- 1264 bottles
- Distribution
- NY only
- Recall date
- December 13, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)