Ambarnath, India
Rubicon Research Private Limited recalls
4 recalls recorded since 2018, most recently on 24 August 2024. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class III Drugs
- Recall started
- 24 August 2024
- Reason
- Discoloration
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0659-2024
- AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01
Ongoing Class II Drugs
- Recall started
- 6 May 2024
- Reason
- Presence of Foreign Substance: metal in tablet
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0517-2024
- Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00
Ongoing Class II Drugs
- Recall started
- 26 April 2024
- Reason
- Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0487-2024
- traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited
Terminated Class II Drugs
- Recall started
- 31 December 2021
- Terminated
- 4 November 2022
- Reason
- Complaint received of foreign matter (metal) embedded in tablet.
- Distribution
- Product was distributed to one distributor who may have distributed the product further nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0362-2022
- Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-
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.