Class II · Moderate risk Ongoing
Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited…
Reason CGMP Deviations
Is Ranolazine recalled?
3 FDA recalls mention Ranolazine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ranolazine.
Class II · Moderate risk Ongoing
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited…
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Class II · Moderate risk Terminated
RANOLAZINE ER Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61958100301
Reason Labeling:Label Mixup; RANOLAZINE ER Tablet, 500 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree…
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