Skip to Content

diclofenac FDA Alerts

The FDA Alert(s) below may be specifically about diclofenac or relate to a group or class of drugs which include diclofenac.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for diclofenac

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Manufactured and Distributed as Altaire Labeled Products

Jul 15, 2019

Audience: Consumer, Health Professional, Pharmacy

July 15, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the over the counter (OTC) and prescription (Rx) drug products and lots, within expiry, it has manufactured and distributed under the Altaire label and trade dress during the time period as indicated below. As a precautionary measure, Altaire is voluntarily initiating this recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. The FDA has determined these issues indicate a lack of sterility assurance. Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.

This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. No other lots are being recalled. A Retail Level recall is limited to product lots currently in inventory on hand at any distributor to which Altaire Pharmaceuticals, Inc. has sold these products.

Altaire further advises as follows:

TO DATE, ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS.

TO DATE, ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATION RESULTS, INCLUDING IN-HOUSE AND THIRD-PARTY STERILITY TESTING, FOR THESE PRODUCTS.

Product Description:

ActivEyes Nighttime Lub Eye Ointment Preservative Free

NDC#: 59390-190-50 Product Size: 3.5 g

Lot Number Expiration Date Manufacturer Initial Ship Date
SKG 11/21 12/28/2018
TAQ 01/22 04/23/2019

Product Description:

Altaire Altacaine Solution

NDC#: 59390-181-13 Product Size: 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
17205 07/19 08/31/2017
17206 07/19 09/13/2017
17271 09/19 11/08/2017
18003 01/20 03/06/2018
18097 04/20 05/11/2018
18166 07/20 07/26/2018
18227 09/20 10/05/2018
18246 10/20 11/16/2018
18317 12/20 12/18/2018
19080 03/21 04/22/2019
19106 04/21 05/21/2019

Product Description:

ActivEyes Altachlore Ointment

NDC#: 59390-184-50 Product Size: 3.5 gram

Lot Number Expiration Date Manufacturer Initial Ship Date
SAP 1/20 3/16/2018
SFI 6/20 8/16/2018
SLA 12/20 1/4/2019
TBM 2/21 3/28/2019

Product Description:

ActivEyes Altachlore Solution

NDC#: 59390-183-13 Product Size: 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
18008 1/20 8/13/2018
19050 2/22 3/18/2019
19105 4/22 6/14/2019

Product Description:

ActivEyes Altalube Ointment

NDC#: 59390-198-50 Product Size: 3.5 gram

Lo Number Expiration Date Manufacturer Initial Ship Date
RJH 10/20 1/10/2018
RLL 12/20 8/22/2018
SGH 07/21 8/23/2018
SIF 09/21 10/16/2018
SKC 11/21 12/12/2018
TCG 03/22 4/22/2019

Product Description:

Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%

NDC#: 59390-217-02 Product Size: 2.5 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
18164 7/20 10/2/2018

Product Description:

Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%

NDC#: 59390-217-05 Product Size: 5 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
18164 7/20 8/15/2018

Product Description:

Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%

NDC#: 59390-217-10 Product Size: 10 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
18164 7/20 8/15/2018

Product Description:

Altaire Diclofenac Sodium Solution 1%

NDC#: 59390-149-02 Product Size: 2.5 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
17247 8/19 11/17/2017

Product Description:

Altaire Diclofenac Sodium Solution 1%

NDC#: 59390-149-05 Product Size: 5 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
17225 8/19 10/16/2017
17247 8/19 12/26/2017
18038 2/20 3/22/2018
18162 6/20 7/18/2018
19014 1/21 2/14/2019

Product Description:

Altaire Fluorescein Sodium with Proparacaine HCl Ophthalmic Solution

NDC#: 59390-205-05 Product Size: 5 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
17099 4/20 6/1/2017
17254 8/20 9/14/2017
17255 8/20 9/15/2017
17361 12/20 12/26/2017
17362 12/20 4/4/2018
18088 4/21 4/30/2018
18089 4/21 5/1/2018
18138 6/21 6/25/2018
18146 6/21 6/29/2018
18156 6/21 8/6/2018
18212 8/21 10/2/2018
18276 11/21 12/26/2018
19082 3/22 5/1/2019
19098 4/22 5/21/2019
16282 10/19 11/11/2016
16283 10/19 01/24/2016

Product Description:

Altaire Eye Wash

NDC#: 59390-175-13 Product Size: 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
17241 8/20 8/24/2017
17322 10/20 12/21/2017
18169 7/20 7/30/2018
19052 2/22 3/29/2019

Product Description:

Altaire Eye Wash

NDC#: 59390-175-18 Product Size: 1 Fl. Oz.

Lot Number Expiration Date Manufacturer Initial Ship Date
17200 7/19 7/28/2017
17322 10/20 11/27/2017
18026 1/21 3/5/2018
18100 4/21 6/18/2018
18236 9/21 11/1/2018
19052 2/22 3/22/2019

Product Description:

Altaire Eye Wash

NDC#: 59390-175-35 Product Size: 4 Fl. Oz.

Lot Number Expiration Date Manufacturer Initial Ship Date
17087 3/20 4/18/2017
17088 3/20 4/28/2017
17109 4/20 5/15/2017
17110 4/20 6/12/2017
17306 10/20 11/1/2017
17307 10/20 11/3/2017
17318 10/20 12/21/2017
17323 10/20 1/30/2018
18014 1/21 4/10/2018
18045 2/21 4/16/2018
18059 3/21 5/29/2018
18063 3/21 4/18/2018
18117 5/21 6/14/2018
18134 5/21 8/24/2018
18228 9/21 11/2/2018
18261 10/21 1/8/2019
19119 4/22 6/3/2019
16207 8/19 09/15/2016
16233 8/19 09/29/2016
16250 9/19 10/28/2016
16268 10/19 11/04/2016
16301 11/19 12/09/2016

Product Description:

Altaire Goniotaire

NDC#: 59390-182-13 Product Size: 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
17112 4/20 6/1/2017
17303 10/20 12/4/2017
18032 2/21 2/22/2018
18072 3/21 4/17/2018
18193 8/20 8/16/2018
18235 9/21 10/15/2018
18285 11/21 12/17/2018
19004 1/22 1/24/2019
19102 4/22 5/15/2019
16260 9/19 10/25/2016

Product Description:

Altaire Homatropaire

NDC#: 59390-192-05 Product Size: 5 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
17041 2/20 6/01/2017
17186 6/20 11/10/2017
18068 3/21 8/17/2018

Product Description:

NanoTears HA PF Multi Dose Lubricant Gel Drops

NDC#: 59390-208-10 Product Size: 10 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
19122 4/21 5/31/2019

Product Description:

Nano Tears MO Clear Emollient Mineral Oil Lipids

NDC#: 59390- 145-10 Product Size: 10 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
18052 2/20 5/16/2018

Product Description:

Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops

NDC#: 59390-144-10 Product Size: 10 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
17367 12/19 2/16/2018
18102 4/20 8/9/2018
18174 7/20 9/11/2018

Product Description:

Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack

NDC#: 59390-144-51 Product Size: 2 x 10 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
17367 12/19 5/16/2018
18174 7/20 8/24/2018

Product Description:

Nano Tears TF Clear Emollient Tear Film Replenishment Essential Lipids Preservative Free Multi-Dose

NDC#: 59390-141-52 Product Size: 7.5 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
19123 4/21 6/07/2019

Product Description:

Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free

NDC#: 59390-147-56 Product Size: 0.6 mL x 32 ct.

Lot Number Expiration Date Manufacturer Initial Ship Date
RGK 7/19 11/6/2017
SDA 4/20 4/27/2018
SFH 6/20 8/16/2018
TAN 1/21 5/23/2019

Product Description:

Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free

NDC#: 59390-141-56 Product Size: 0.6 mL x 32 ct.

Lot Number Expiration Date Manufacturer Initial Ship Date
RGI 7/19 1/5/2018
SDB 4/20 5/16/2018
TAA 1/21 3/13/2019

Product Description:

Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack

NDC#: 59390-142-49 Product Size: 2 x 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
18033 2/20 8/10/2018

Product Description:

Nano Tears TF Clear Emollient Lubricant Gel Drops

NDC#: 59390-142-13 Product Size: 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
18033 2/20 06/04/2018

Product Description:

Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack

NDC#: 59390-143-51 Product Size: 2 x 10 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
17366 12/19 1/31/2018

Product Description:

Nano Tears XP Clear Emollient Lubricant Gel Drops

NDC#: 59390-143-10 Product Size: 10 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
17366 12/19 1/5/2018
18103 /20 7/9/2018
18173 7/20 8/3/2018

Product Description:

Altaire Ofloxacin 0.3% Ophthalmic Solution USP

NDC#: 59390-140-05 Product Size: 5 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
17244 8/19 10/9/2017
18057 3/20 5/15/2018
18307 12/20 1/9/2019

Product Description:

ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF

NDC#: 59390-148-52 Product Size: 7.5 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
19015 1/21 4/2/2019

Product Description:

ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF

NDC#: 59390-146-52 Product Size: 7.5 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
18099 4/20 4/2/2019

Product Description:

ActivEyes Lubricant Eye Ointment Preservative Free

NDC#: 59390-189-50 Product Size: 3.5 gram

Lot Number Expiration Date Manufacturer Initial Ship Date
SFE 06/21 4/23/2019

The foregoing products are manufactured and labeled by Altaire Pharmaceuticals, Inc. Altaire has notified all distributors by e-mail on July 15, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots. Any questions regarding this VOLUNTARY RECALL to the RETAIL LEVEL can be directed to Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday thru Friday from 8:30 a.m. to 5:00 p.m. ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Altaire takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility.

Source: FDA

Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication - FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke

Jul 9, 2015

Audience: Health Professional, Consumer

[Posted 07/09/2015]

ISSUE:  FDA is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on FDAs comprehensive review of new safety information, FDA is requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels. See the FDA Drug Safety Communication (Table 1) for a list of non-aspirin nonsteroidal anti-inflammatory drug products.

Prescription NSAID labels will be revised to reflect the following information:

  • The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
  • The risk appears greater at higher doses.
  • It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
  • NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
  • In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
  • Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
  • There is an increased risk of heart failure with NSAID use.

BACKGROUND: The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Since then, FDA reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies, a large combined analysis of clinical trials, and other scientific publications. These studies were also discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held on February 10-11, 2014.

RECOMMENDATION: Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken. Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[07/09/2015 - Drug Safety Communication - FDA]

[07/09/2015 - Nonsteroidal Anti-inflammatory Drugs (NSAIDs) - FDA]

More diclofenac Resources