Indocin Suppositories (G&W) – Impurity Specifications (2017)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
G & W Laboratories, Inc.
Lot Codes / Batch Numbers
Lot #: 017600011, Exp. Jan 2018, 0176000014, Exp. Aug 2018, 017600015, Exp. Sep 2018
Products Sold
Lot #: 017600011, Exp. Jan 2018, 0176000014, Exp. Aug 2018, 017600015, Exp. Sep 2018
G & W Laboratories, Inc. is recalling Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Ma due to Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered d. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026