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FDAFebruary 7, 2017drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

g w laboratories

UPCs

42211010243

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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