March 2019 FDA Recall Drug by H J Harkins Company Inc Dba Pharma Pac
D-1083-2019 - CGMP Deviations

This Class II drug recall was voluntarily initiated by H J Harkins Company Inc Dba Pharma Pac on March 4, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to a physician's office in California. and the recall is currently terminated.

Recall Number: D-1083-2019

Reason for Recall
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
Initiated
03-04-2019
Reported
04-17-2019
Quantity
300 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82574
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.
H J Harkins Company Inc dba Pharma Pac
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.
Product was distributed to a physician's office in California.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-24-2023
Product Description About Product Description
Full technical description of the product.
Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.

Batch or Lot Expiration Information

Lot# Pharma Pac NDC: 76519-1033-03, Pharma Pac
Lot# LTO00EW, Exp. 11/19, MFG NDC 31722-0702-30, MFG
Lot# LOP17087, Exp. 11/2019.