US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 7, 2017 (10 years ago)

Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30…

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

Why it was recalled

Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.

What was recalled

Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W Laboratories Inc. South Plainfield, NJ 07080, Distributed by Iroko Pharmaceuticals, LLC Philadelphia, PA 19112, NDC 42211-0102-43

Recalling firm
G & W Laboratories, Inc.
NDC code
42211-0102-43
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0501-2017

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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