CLASS II Drug recall · Reported 27 Jan 2016 · FDA Enforcement Report

Bromfenac Ophthalmic Solution 0.09%, a) bottles recalled

Mayne Pharma Usa is recalling Bromfenac Ophthalmic Solution 0.09%, a) bottles (, distributed nationwide in the US. The recall was initiated on 5 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) Lot numbers: 0378-7110-35 AD4819, Exp. Date: 08-2016; 0378-7110-35 AC7894, Exp. Date: 05-2016; 0378-7110-35 AD2527, Exp. Date: 06-2016; 0378-7110-35 AC6330, Exp. Date: 05-2016; 0378-7110-35 AC2330, Exp. Date: 04-2016 and b) Lot numbers: 0378-7109-35 AD4515, Exp. Date: 04-2016 and 0378-7109-35 AC2328, Exp. Date: 01-2016.

Quantity recalleda) 52034 bottles and b) 22074 bottles

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-0585-2016
FDA event ID: 73072
Recalling firm: Mayne Pharma Usa, Greenville, NC
Classification: Class II
Status: Terminated
Recall initiated: 5 Jan 2016
FDA classified: 20 Jan 2016
Reported: 27 Jan 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Eye Drops

Timeline

5 Jan 2016	Recall initiated by company
20 Jan 2016	Classified by FDA	+15 days
27 Jan 2016	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

Lack of Assurance of Sterility: Failed preservative effectiveness test

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: Failed preservative effectiveness test

Which lots are affected?

a) Lot numbers: 0378-7110-35 AD4819, Exp. Date: 08-2016; 0378-7110-35 AC7894, Exp. Date: 05-2016; 0378-7110-35 AD2527, Exp. Date: 06-2016; 0378-7110-35 AC6330, Exp. Date: 05-2016; 0378-7110-35 AC2330, Exp. Date: 04-2016 and b) Lot numbers: 0378-7109-35 AD4515, Exp. Date: 04-2016 and 0378-7109-35 AC2328, Exp. Date: 01-2016.

Where was it sold?

Nationwide

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.

Other Bromfenac recalls

All 7

Reported	Class	Recall	Company	Reason	Where
4 Jun 2025Drug	CLASS II	Bromfenac Ophthalmic Solution recalled by Alembic PharmaceuticalsBromfenac Ophthalmic Solution 0.09%	Alembic Pharmaceuticals	Potency & Assay	Nationwide
2 Jun 2021Drug	CLASS II	Bromfenac Ophthalmic Solution recalled by Cardinal HealthBromfenac Ophthalmic Solution 0.09%	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
6 Feb 2019Drug	CLASS II	BromSite (bromfenac ophthalmic solution) recalledBromsite	Sun Pharmaceutical Industries	Sterility	Nationwide
21 Oct 2015Drug	CLASS II	Bromfenac Ophthalmic Solution recalled by Apotex	Apotex	Sterility	Nationwide
26 Aug 2015Drug	CLASS II	Bromfenac Ophthalmic Solution recalled by Bausch & Lomb	Bausch & Lomb	Sterility	Nationwide