Drug recall: AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro…
Class III FDA enforcement event 95217. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Discoloration
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Rubicon Research Private Limited started this drug recall on 24 Aug 2024. The firm address in the FDA record is in Ambarnath. FDA put the recall in Class III. FDA event 95217 has 1 product record. The first FDA enforcement report date is 25 Sep 2024. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide in the US
Recalling firm
Rubicon Research Private Limited, Ambarnath, India.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 | 3,984 bottles | Class III | Ongoing | 25 Sep 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Drug events that started in 2024
- 319
- Share of these events in Class III
- 15%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 6 May 2024 | Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manu | Drug | Class II | 1 |
| 26 Apr 2024 | traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plain | Drug | Class II | 1 |
| 31 Dec 2021 | Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; M | Drug | Class II | 1 |
Official channels
- FDA enforcement report D-0659-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 95217. https://recallregister.com/fda/iii/95217/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide in the US
- What quantity of product is in FDA event 95217?
- The FDA record gives this quantity:
3,984 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2024 have the same class?
- 15% of the 319 drug events that started in 2024 are in Class III.