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
Reported: March 8, 2017 Initiated: February 7, 2017 #D-0501-2017
Product Description
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.
Details
- Recalling Firm
- G & W Laboratories, Inc.
- Units Affected
- 3456 boxes
- Distribution
- Within United States
- Location
- South Plainfield, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by G & W Laboratories, Inc.. Units affected: 3456 boxes.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 8, 2017. Severity: Moderate. Recall number: D-0501-2017.
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