Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot #: 017600011, Exp. Jan 2018, 0176000014, Exp. Aug 2018, 017600015, Exp. Sep 2018
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Recalling firm
- Firm
- G & W Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 Coolidge St, N/A, South Plainfield, New Jersey 07080-3895
Distribution
- Quantity
- 3456 boxes
- Distribution pattern
- Within United States
Timeline
- Recall initiated
- 2017-02-07
- FDA classified
- 2017-03-01
- Posted by FDA
- 2017-03-08
- Terminated
- 2018-06-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0501-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.