Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmac...
FDA Recall #D-0092-2018 — Class II — November 17, 2017
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.
Recalling Firm
Lupin Limited — Vasco Da Gama, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Product was distributed throughout the United States, including Puerto Rico.
Code Information
Lot # G702459, Exp 2/20
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated