CLASS II Drug recall · Reported 7 Aug 2019 · FDA Enforcement Report

Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g recalled

H J Harkins is recalling Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic, distributed in California. The recall was initiated on 12 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 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

Quantity recalled97 boxes

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1580-2019
FDA event ID: 83339
Recalling firm: H J Harkins, Grover Beach, CA
Classification: Class II
Status: Terminated
Recall initiated: 12 Jul 2019
FDA classified: 31 Jul 2019
Reported: 7 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Eye Drops

Timeline

12 Jul 2019	Recall initiated by company
31 Jul 2019	Classified by FDA	+19 days
7 Aug 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.

Product as listed by the FDA

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

Where it was distributed

Distributed in California

California

Questions about this recall

Why was it recalled?

CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.

Which lots are affected?

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

Where was it sold?

Distributed in California

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from H J Harkins

All 9

Reported	Class	Recall	Company	Reason	Where
22 Apr 2020Drug	CLASS II	Acetaminophen and Codeine Phosphate recalled by H J Harkins Company	H J Harkins	Manufacturing (CGMP) Deviations	AZ, CA
18 Mar 2020Drug	CLASS II	Acetaminophen 500 mg tablet packaged in a) 30-count bottles recalled	H J Harkins	Packaging Defects	Nationwide
29 Jan 2020Drug	CLASS II	Ranitidine, a), b), c), d), e) recalled by H J Harkins Company	H J Harkins	Nitrosamine Impurity	4 states
3 Jul 2019Drug	CLASS II	Diphenhydramine HCL Liquid, 12.5 mg recalled by H J Harkins Company	H J Harkins	Sterility	Nationwide
3 Jul 2019Drug	CLASS II	Acetaminophen Children's Liquid, 160 mg recalled by H J Harkins Company	H J Harkins	Sterility	Nationwide

Other Neomycin recalls

All 12

Reported	Class	Recall	Company	Reason	Where
25 Jan 2023Drug	CLASS II	Neomycin and Polymyxin B Sulfates recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide
7 Sep 2022Drug	CLASS II	Neomycin Sulfate Tablets, USP 500 mg recalledNeomycin Sulfate	Teva Pharmaceuticals USA	Foreign Material	Nationwide
15 Jun 2022Drug	CLASS II	Neomycin and Polymyxin B Sulfates recalled by Mckesson Medical-SurgicalNeomycin And Polymyxin B Sulfates And Dexamethasone	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
2 Jun 2021Drug	CLASS II	Neomycin Sulf Tablets, USP, 500mg recalled by Cardinal HealthNeomycin Sulfate	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
14 Apr 2021Drug	CLASS II	Neomycin Sulfate Tablets, USP 500mg recalled by X-Gen Pharmaceuticals	X-Gen Pharmaceuticals	Potency & Assay	Nationwide