Parsippany, NJ, United States
Granules USA, Inc. recalls
1 recall recorded since 2018, most recently on 11 August 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 11 August 2021
- Terminated
- 16 February 2023
- Reason
- CGMP Deviations
- Distribution
- NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0777-2021
- Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village, Dundigal-Gandimalsamma Monday, Medchai-Maikhajgir District - 500043, Telanga
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.