Home / Recalls / Lupin Limited / D-0092-2018

D-0092-2018 Class II Terminated

Recalled by Lupin Limited — Vasco Da Gama, N/A

FDA drug recall D-0092-2018 was initiated by Lupin Limited on Nov 17, 2017 and is designated Class II. 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… The recall status is terminated (terminated Mar 15, 2019).

Recall Details

Product Type: Drugs
Report Date: Nov 29, 2017
Initiation Date: Nov 17, 2017
Termination Date: Mar 15, 2019
Voluntary/Mandated: Voluntary: Firm initiated

Product Description

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.

Distribution Pattern

Product was distributed throughout the United States, including Puerto Rico.

Code Information

Lot # G702459, Exp 2/20

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0092-2018
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.