ALTAIRE PHARMACEUTICALS, INC.: Issues Voluntary Recall Of Veterinary Ophthalmic Products

Altaire Pharmaceuticals, Inc. issued the following announcement on Aug. 22.

Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Veterinary ophthalmic drug products and lots, within expiry, identified below. This recall is only for the specific lots listed. No other lots are being recalled. 

Altaire is initiating the recall due to concerns regarding some QA controls in the manufacturing facility. The recalled products will be evaluated as part of Altaire's review. As of this date, Altaire is pleased to state that they have not received any reports of adverse events from the use of the recalled products and lot #'s.

Product Description: Vetropolycin Ophthalmic Ointment NDC Number: 17033-028-38  Package Size: 3.5 gm  Lot #:/ Exp. Date: 17245/RHG (08/19), 17246/RHH (08/19), 17265/RHQ  (09/19), 17305/RJE (10/19), 17329/RKD (11/19), 17330/RKE (11/19), 17331/RKF (11/19), 17245/RHG (08/19), 17246/RHH (08/19), 17265/RHQ  (09/19), 17305/RJE (10/19), 17329/RKD (11/19), 17330/RKE (11/19), 17331/RKF (11/19), 17382/RLJ (12/19), 17383/RLK (12/19), 18010/SAF (01/20), 18011/SAG (01/20), 18233/SIG (09/20), 18234/SIH (09/20), 18270/SKA (11/20), 18271/SKB (11/20), 18312/SLH (12/20), 18313/SLI (12/20), 19019/TAI (01/21), 19020/TAJ  (01/2), 19024/TAL (01/21), 19067/TCE (03/21), 19097/TDA (04/21).

Product Description: Vetropolycin HC Ophthalmic Ointment NDC Number: 17033-030-88 Package Size: 3.5 gm Lot #:/ Exp. Date: 17243/RHF (08/19), 17324/RJQ (10/19), 17326/RKA (11/19), 17327/RKB (11/19), 17328/RKC (11/19), 17389/RLN (12/19), 18013/SAH (01/20), 18028/SAQ (01/20), 18039/SBD (02/20), 19118/TDK (04/21).

Product Description: Puralube Vet Ophthalmic Ointment NDC Number:  17033-211-38  Package Size: 3.5 gm Lot #:/ Exp. Date: 17246/RHH (08/19), 17265/RHQ (09/19), 17305/RJE (10/19), 17329/RKD (11/19), 17330/RKE (11/19), 17331/RKF (11/19), 17382/RLJ (12/19), 17383/RLK (12/19), 18010/SAF (01/20), 18011/SAG (018/20), 18233/SIG (09/20), 18234/SIH (09/20), 18270/SKA (11/20), 18271/SKB (11/20), 18312/SLH (12/20), 18313/SLI (12/20), 19019/TAI (01/21), 19020/TAJ (01/21), 19024/TAL (01/21), 19067/TCE (03/21), 19097/TDA (04/21)

The products are manufactured and labeled exclusively for Dechra Veterinary Products.  Altaire ships the products only to Dechra Veterinary Products. The products are distributed by Dechra Veterinary Products. 

Altaire has notified Dechra by e-mail on August 22, 2019 announcing the recalls of the products/lots identified herein, with specific directions to recall all units of the impacted lots.  Altaire has also asked  Dechra to notify their downstream supply chain partners of the recall, and perform a sub-recall to the retail level. 

Dechra customers with questions regarding this recall can contact Dechra directly by calling 1-866-933-2472, or e-mailing support@dechra.com. Pet Owners should contact their veterinary care provider if they have any questions.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's Center for Veterinary Medicine (CVM) program by using FORM FDA 1932a "Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report" as follows:

• Online: submit fillable form  found at https://www.fda.gov/media/125072/download via email to CVM1932a@fda.hhs.gov
• Regular Mail: mail form available at www.fda.gov/MedWatch/getforms.htm to Center for Veterinary Medicine Food and Drug Administration HFV-1 7500 Standish Place Rockville, MD 20855.

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. 

Original source can be found here.