August 2019 FDA Recall Drug by Remedyrepack Inc.
D-1030-2020 - Presence of Foreign Tablets/Capsules

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on August 5, 2019 for the product Drug. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed in PA and the recall is currently terminated.

Recall Number: D-1030-2020

Reason for Recall
Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product bottle.
Initiated
08-05-2019
Reported
03-25-2020
Quantity
480 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83645
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
RemedyRepack Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-02-2023
Product Description About Product Description
Full technical description of the product.
Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0519-02 (Original NDC of 500 count bottle); 70518-0382-03 (Repackaged NDC for blister cards).

Batch or Lot Expiration Information

Lot# : J0322819-091418, Exp: 09/30/2019