FDA Drug recall D-0233-2018
Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispen…
- FDA Drug
- Class II
- terminated
- Published 2018-01-31
On 2018-01-31 the FDA classified a Class II recall of Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispen… by International Laboratories, citing presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0233-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-12 |
| Published | 2018-01-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | International Laboratories |
| Distribution | US |
Product
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.
Reason
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Identifiers
| code_info | Lot: 117093A, Exp. 06/19 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0233-2018%22
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