Class II · Moderate risk Ongoing
Ranolazine Extended-Release Tablets 1000mg
Reason CGMP Deviations
RANOLAZINE ER Tablet
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling:Label Mixup; RANOLAZINE ER Tablet, 500 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD25452_16, EXP: 5/3/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: AD70585_16, EXP: 5/29/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W002852, EXP: 6/7/2014; VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree:
What was recalled
RANOLAZINE ER Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61958100301
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-667-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Ranolazine recalls
See all
Class II · Moderate risk Ongoing
Ranolazine Extended-Release Tablets 500mg
Reason Failed Dissolution Specifications: Out of specification for dissolution.
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