FDA-Drug2017-03-08Class II
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
G & W Laboratories, Inc.
Hazard
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Sold states
Within United States
Affected count
3456 boxes
Manufactured in
111 Coolidge St, N/A, South Plainfield, NJ, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0501-2017Don't want to check this manually?
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