Ajanta Pharma USA Inc: Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Ajanta Pharma USA Inc
- Product
- Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02
- Reason / hazard
- Failed Dissolution Specifications: below specification
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide in the US.
- Recall initiated
- 2026-09-17
- Code info
- Lot: DJ25134, Exp 11/30/2028
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Bridgewater
- State
- NJ
- Country
- United States
- Event id
- 99893
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