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Bronchodilator Recall Active

August 14, 2017

Teva Pharmaceuticals USA is recalling albuterol sulfate inhalation solution, 0.021% (0.63 mg/3 mL), packaged in 5 pouches of 5 x 3 mL sterile unit-dose vials for inhalation per carton, according to the August 9, 2017, US Food and Drug Administration (FDA) Enforcement Report.

The medication failed to meet impurity/degradation specifications.

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Over 500,000 Inhalers Recalled

The recall affects 401,750 cartons of albuterol sulfate inhalation solution (NDC 0591-3467-53) from the following lots: 

  • GA60206 and GA60207 (Exp. 8/17);
  • GA60283 and GA60284 (Exp. 9/17);
  • GA60378, GA60379, and GA60478 (Exp. 10/17);
  • GA60491 (Exp. 11/17);
  • GA60615 and GA60616 (Exp. 12/17);
  • GA60719, GA60720, GA60721, GA60749, GA60750, and GA60751 (Exp. 1/18); and
  • GA70001, GA70031, GA70046, GA70047, GA70074, and GA70075 (Exp 6/18).

The products were distributed in the United States, including Puerto Rico.

Teva Pharmaceuticals USA initiated the voluntary recall July 25, 2017. The FDA designated it class III July 31, 2017. Per the classification, serious adverse health consequences from use of the recalled product are unlikely.

Albuterol sulfate inhalation solution is a prescription bronchodilator for the prevention or treatment of bronchospasm in patients with reversible obstructive airway disease.

Jolynn Tumolo

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