Drug recall: Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC…

Class II FDA enforcement event 72341. Recall start date: 25 Aug 2015. Status in the FDA record: Terminated. Termination date: 15 Jun 2022.

Reason for recall, in the words of FDA

Lack of Assurance of Sterility: Failed preservative effectiveness testing

Class II, in the words of FDA

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

Apotex Inc. started this drug recall on 25 Aug 2015. The firm address in the FDA record is in Toronto. FDA put the recall in Class II. FDA event 72341 has 1 product record. The first FDA enforcement report date is 21 Oct 2015. The record gives the status Terminated, with the termination date 15 Jun 2022.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide

Recalling firm

Apotex Inc., Toronto, N/A, Canada.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 72341: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0009-2016	Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.	5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)	Class II	Terminated	21 Oct 2015

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2015: 292
Share of these events in Class II: 52%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 20

Other events of the firm

Other FDA enforcement events of Apotex Inc.
Initiated	Product (first record)	Type	Class	Records
27 May 2020	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. T	Drug	Class II	1
22 Oct 2019	Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Ca	Drug	Class III	1
24 Sep 2019	Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wil	Drug	Class II	6
1 Mar 2019	Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as	Drug	Class II	1
31 May 2018	Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill	Drug	Class II	1
8 May 2018	Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by:	Drug	Class I	2
3 Feb 2017	CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Ma	Drug	Class II	1
19 Dec 2016	Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; M	Drug	Class III	1
17 Aug 2015	Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex	Drug	Class II	1
21 Jul 2015	Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by	Drug	Class III	1

Apotex Inc.: all 20 events

Official channels

FDA enforcement report D-0009-2016The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 72341. https://recallregister.com/fda/ii/72341/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide
What quantity of product is in FDA event 72341?: The FDA record gives this quantity: 5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2015 have the same class?: 52% of the 292 drug events that started in 2015 are in Class II.