Drug 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
D-0501-2017
Product summary
- Event
- Event 76430
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3456 boxes
- Official record key
drug-enforcement:D-0501-2017
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Code information: Lot #: 017600011, Exp. Jan 2018, 0176000014, Exp. Aug 2018, 017600015, Exp. Sep 2018
Distribution pattern: Within United States
Derived failure modes
-
Potency or specification failure
Out of specification