Drug recall: Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient…
Class II FDA enforcement event 78939. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
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
International Laboratories, Inc. started this drug recall on 12 Jan 2018. The firm address in the FDA record is in Seminole, FL. FDA put the recall in Class II. FDA event 78939 has 2 product records. The first FDA enforcement report date is 31 Jan 2018. The record gives the status Terminated, with the termination date 1 May 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
Recalling firm
International Laboratories, Inc., Seminole, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0233-2018 | Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser cartons, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-927-16. | 9,052 cartons | Class II | Terminated | 31 Jan 2018 |
| D-0234-2018 | Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser carton, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-926-16. | 13,403 cartons | Class II | Terminated | 31 Jan 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 II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2018
- 367
- Share of these events in Class II
- 60%
- Product records in this event
- 2Median of the firm: 2
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 Aug 2017 | Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Pet Event 77899 | Drug | Class I | 1 |
Official channels
- FDA enforcement report D-0233-2018The 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 78939. https://recallregister.com/fda/ii/78939/. 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
- What quantity of product is in FDA event 78939?
- The event has 2 product records. The first record gives this quantity:
9,052 cartons
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2018 have the same class?
- 60% of the 367 drug events that started in 2018 are in Class II.