Pravastatin Sodium USP — Class II drug recall D-0092-2018
Terminated recall by Lupin Limited, reported 2017-11-29, distributed nationwide. Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one
| Recall number | D-0092-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Limited, Vasco Da Gama, N/A, India |
| Recall initiated | 2017-11-17 |
| Classified | 2017-11-21 |
| Reported by FDA | 2017-11-29 |
| Terminated | 2019-03-15 |
| Distributed | Nationwide (US) |
| NDC | 68180-0485, 68180-0485-02, 68180-0485-03, 68180-0485-09, 68180-0486, 68180-0486-02, 68180-0486-03, 68180-0486-09, 68180-0487, 68180-0487-02, 68180-0487-03, 68180-0487-09, 68180-0488, 68180-0488-02, 68180-0488-03, 68180-0488-09 |
| Lot numbers | 2/20, G702459 |
Product
Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09
Reason for recall
Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0092-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.