Class II
Terminated
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
This recall has been terminated (originally issued March 8, 2017).
- Company
- G & W Laboratories Inc
- Recall Initiated
- February 7, 2017
- Posted
- March 8, 2017
- Recall Number
- D-0501-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3456 boxes
- Firm Location
- South Plainfield, NJ, United States
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot #: 017600011, Exp. Jan 2018, 0176000014, Exp. Aug 2018, 017600015, Exp. Sep 2018
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