G & W Laboratories, Inc. recalls Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W L
Recalled March 8, 2017 · FDA recall D-0501-2017 · G & W Laboratories
Hazard
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing. · FDA Class II
Units
3456 boxes
Sold at
Within United States
Description
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Product
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
Manufacturer(s)
G & W Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →