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Altaire issues voluntary recall of veterinary ophthalmic drugs

The company says it’s received no reports of adverse events so far

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Altaire Pharmaceuticals has issued a voluntary recall of some of its veterinary ophthalmic drug products and lots over quality assurance concerns.

According to the company, the products are manufactured and labeled exclusively for Dechra Veterinary Products.

The recalled products are:

  • 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).
  • 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).
  • 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)

“Altaire takes its mission of customer safety and providing quality products very seriously,” the company says. “[We are] committed to, and diligently working to, ensure the sufficiency of quality assurance controls over critical systems in [our] manufacturing facility.”

According to Altaire, the recall is only for the specific lots listed above. The recalled products will be evaluated as part of Altaire’s review. So far, there have been no reports of adverse events from the use of the recalled products and lot numbers.

According to the U.S. Food and Drug Administration (FDA), Altaire alerted Dechra by email on Aug. 22 that it was recalling certain products and lots. The pharmaceutical company also asked Dechra to notify its downstream supply chain partners of the recall, and perform a sub-recall to the retail level.

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Dechra customers with questions regarding this recall can contact the company directly at (866) 933-2472 or by emailing 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.” It can be submitted online, by fax at (800) FDA-0178, or by mail using the pre-addressed form.

 

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