COMPANY ANNOUNCEMENT
Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Manufactured and Distributed as Altaire Labeled Products
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read AnnouncementSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason DescriptionDue to lack of sterility assurance
- Company Name:
- Altaire Pharmaceuticals Inc.
- Brand Name:
-
Brand Name(s)Altaire Pharmaceuticals, Inc.
- Product Description:
-
Product DescriptionOTC and Rx Ophthalmic Products
Company Announcement
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.
Company Contact Information
- Consumers:
- Altaire Pharmaceuticals Inc.
- 1-800-258-2471
- otcdruggist@aol.com
- Media:
- Michael Sawaya
- 1-800-258-2471