Reported Mar 8, 2017 · Terminated
Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W…
G & W Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: G & W Laboratories, Inc. · 111 Coolidge St · South Plainfield, NJ · 07080-3895
Is this the product you have?
- Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only
- Manufactured byG&W Laboratories Inc. South Plainfield, NJ 07080, Distributed by Iroko Pharmaceuticals, LLC Philadelphia, PA 19112, NDC 42211-0102-43
- Lot codes and dates
Lot #: 017600011Exp. Jan 20180176000014Exp. Aug 2018017600015Exp. Sep 2018
- Amount recalled
- 3456 boxes
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.
This product could cause temporary or reversible health problems — stop using it.
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