July 2019 FDA Recall Drug by H J Harkins Company Inc Dba Pharma Pac
D-1580-2019 - CGMPs Deviations

This Class II drug recall was voluntarily initiated by H J Harkins Company Inc Dba Pharma Pac on July 12, 2019 for the product Drug. The FDA reported the reason for recall as cgmps deviations. The product was distributed in Distributed in California and the recall is currently terminated.

Recall Number: D-1580-2019

Reason for Recall
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Initiated
07-12-2019
Reported
08-07-2019
Quantity
97 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83339
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.
Distributed in California
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-05-2023
Product Description About Product Description
Full technical description of the product.
Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufactured for H.J. Harkins Company, Inc. dba Pharma Pac by Perrigo Co, Allegan, MI 49010, NDC 52959-0407-01

Batch or Lot Expiration Information

Lot# : NPD10RP, Exp 08/19; NPD11RP, Exp 09/19; NPD12RP, Exp 11/19; NPD13RP, Exp 02/20; NPD14RP, Exp 02/20; NPD15RP, Exp 05/20; NPD16RP, Exp 06/20; NPD17RP, Exp 01/21; NPD18RP, Exp 02/21