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.
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
Lot numbers, UPCs & expiration codes
Lot #: 017600011, Exp. Jan 2018, 0176000014, Exp. Aug 2018, 017600015, Exp. Sep 2018
Where it was sold
Within United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0501-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 7, 2017
- FDA report date
- Mar 8, 2017
- Quantity
- 3456 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- G & W Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0501-2017, exactly as published.
Show all FDA fields
- City
- South Plainfield
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76430
- Address
- 111 Coolidge St
- Code information
- Lot #: 017600011, Exp. Jan 2018, 0176000014, Exp. Aug 2018, 017600015, Exp. Sep 2018
- Postal code
- 07080-3895
- Report date
- Mar 8, 2017
- Product type
- Drugs
- Recall number
- D-0501-2017
- Classification
- Class II
- Recalling firm
- G & W Laboratories, Inc.
- Product quantity
- 3456 boxes
- Termination date
- Jun 18, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Within United States
- Recall initiation date
- Feb 7, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 1, 2017