US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 25, 2012 (14 years ago)

Aminophylline 20ml, Sdv** 500mg (25mg/Ml) Injectable 20 Ml (1 Product)

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

What was recalled

AMINOPHYLLINE 20ML, SDV** 500MG (25MG/ML) INJECTABLE 20 ML (1 PRODUCT)

Recalling firm
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1455-2012

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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