FDAFDA · Food and drugs·Recall number D-0501-2017
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
Published March 8, 2017 · Recall initiated: February 7, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- G & W Laboratories, Inc.
- Distributor
- Within United States
- Lot
- Lot #: 017600011, Exp. Jan 2018, 0176000014, Exp. Aug 2018, 017600015, Exp. Sep 2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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