October 2018 FDA Recall Drug by H J Harkins Company Inc Dba Pharma Pac
D-0415-2019 - Presence of Particulate Matter

This Class II drug recall was voluntarily initiated by H J Harkins Company Inc Dba Pharma Pac on October 18, 2018 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0415-2019

Reason for Recall
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Initiated
10-18-2018
Reported
02-06-2019
Quantity
84, 5 ml bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81343
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.
Nationwide in the USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-06-2021
Product Description About Product Description
Full technical description of the product.
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00

Batch or Lot Expiration Information

Lot# GNT01AK, Exp. 02/19 & GNT07AK, Exp. 3/20