November 2017 FDA Recall Pravastatin Sodium by Lupin Limited
D-0092-2018 - Presence of foreign tablets/capsules
This Class II drug recall was voluntarily initiated by Lupin Limited on November 17, 2017 for the product Pravastatin Sodium. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed in Product was distributed throughout the United States, including Puerto Rico. and the recall is currently terminated.
Recall Number: D-0092-2018
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.
11-17-2017
11-29-2017
N/A
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lupin Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed throughout the United States, including Puerto Rico.
03-15-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09
Batch or Lot Expiration Information
Lot# G702459, Exp 2/20
