FDA recall D-0501-2017

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.

Distribution

Within United States

Key facts

Status

Terminated

Initiation date

2017-02-07

Report date

2017-03-08

Termination date

2018-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

South Plainfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0501-2017