Indocin — Class II drug recall D-0501-2017
Terminated recall by G & W Laboratories, Inc., reported 2017-03-08. Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend f
| Recall number | D-0501-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | G & W Laboratories, Inc., South Plainfield, NJ, United States |
| Recall initiated | 2017-02-07 |
| Classified | 2017-03-01 |
| Reported by FDA | 2017-03-08 |
| Terminated | 2018-06-18 |
| Quantity | 3,456 boxes |
| Reason classes | specification failure |
| NDC | 42211-0102-43 |
| Lot numbers | 0176000014, 017600011, 017600015 |
| Expiration dates | 2018-01-20, 2018-08-20, 2018-09-20 |
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
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0501-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.