Elite Laboratories Inc. recalls Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 076…
- Recall date
- November 13, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0107-2018
- FDA classification
- Class III
- Brand / firm
- Elite Laboratories Inc.
- Sold / distributed
- NY only
Why it was recalled
Failed Impurities/Degradation Specifications
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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