Qutbullapur Mandal, Ranga Redd, N/A, India
Granules India Limited recalls
1 recall recorded since 2018, most recently on 13 December 2019. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 13 December 2019
- Reason
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- Distribution
- OR, NY, NJ
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0632-2020
- RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.