Drug recall: Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam…
Class III FDA enforcement event 80275. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Failed Impurities/Degradation Specifications
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
The recalling firm started this drug recall on 12 Jun 2018. The FDA record names a person as the firm, and this site does not show the name. The firm address in the FDA record is in Princeton, NJ. FDA put the recall in Class III. FDA event 80275 has 3 product records. The first FDA enforcement report date is 27 Jun 2018. The record gives the status Terminated, with the termination date 8 Nov 2019.
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 USA and Puerto Rico
Recalling firm
The name is withheld, Princeton, NJ.
The FDA record gives the name of a person as the recalling firm. This site does not show the names of persons.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0886-2018 | Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90 | 55,126 bottles | Class III | Terminated | 27 Jun 2018 |
| D-0887-2018 | Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90 | 44,894 bottles | Class III | Terminated | 27 Jun 2018 |
| D-0888-2018 | Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA | 130,081 bottles | Class III | Terminated | 27 Jun 2018 |
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 2018
- 367
- Share of these events in Class III
- 29%
- Product records in this event
- 3
Official channels
- FDA enforcement report D-0886-2018The 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 80275. https://recallregister.com/fda/iii/80275/. 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 USA and Puerto Rico
- What quantity of product is in FDA event 80275?
- The event has 3 product records. The first record gives this quantity:
55,126 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2018 have the same class?
- 29% of the 367 drug events that started in 2018 are in Class III.