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Bronchodilator Recalled

April 03, 2020

Nostrum Laboratories Inc. is recalling more than 4700 bottles of theophylline (anhydrous) extended-release tablets, 400 mg. According to the April 1, 2020, US Food and Drug Administration (FDA) Enforcement Report, the product was labeled with incorrect lot and expiration date information. 

Recalled are 100-count bottles (NDC 29033-001-01) from lot THE190501 (Exp. 11/22), which were distributed in Tennessee and Missouri.   

Nostrum Laboratories voluntarily initiated the recall March 6, 2020. On March 25, 2020, the FDA designated the recall Class II, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm. 

Theophylline is a prescription bronchodilator used to treat asthma, emphysema, and chronic bronchitis.  

Jolynn Tumolo

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