Drug recall: Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd.…
Class II FDA enforcement event 84516. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Glenmark Pharmaceuticals Inc., USA started this drug recall on 17 Dec 2019. The firm address in the FDA record is in Mahwah, NJ. FDA put the recall in Class II. FDA event 84516 has 6 product records. The first FDA enforcement report date is 15 Jan 2020. 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.
Natiowide
Recalling firm
Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0639-2020 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60 | 208,668 bottles | Class II | Ongoing | 15 Jan 2020 |
| D-0640-2020 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01 | 217,956 bottles | Class II | Ongoing | 15 Jan 2020 |
| D-0641-2020 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30 | 98,988 bottles | Class II | Ongoing | 15 Jan 2020 |
| D-0642-2020 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01 | 1,309,536 bottles | Class II | Ongoing | 15 Jan 2020 |
| D-0643-2020 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20 | 500,960 bottles | Class II | Ongoing | 15 Jan 2020 |
| D-0644-2020 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-05 | 1,712,632 bottles | Class II | Ongoing | 15 Jan 2020 |
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 II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2019
- 362
- Share of these events in Class II
- 68%
- Product records in this event
- 6Median of the firm: 1
- Events of the firm on the register
- 55
Other events of the firm
Official channels
- FDA enforcement report D-0639-2020The 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.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 84516. https://recallregister.com/fda/ii/84516/. 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:
Natiowide
- What quantity of product is in FDA event 84516?
- The event has 6 product records. The first record gives this quantity:
208,668 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2019 have the same class?
- 68% of the 362 drug events that started in 2019 are in Class II.