FDAFDA · Food and drugs·Recall number D-0606-2018
Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01.
Published April 4, 2018 · Recall initiated: March 19, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- INDOMETHACIN
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Nationwide in the United States.
- UPC
- 0368462406014
- Lot
- Lot #: 19172776, 19172794, Exp 07/19; 19173111, 19173186, 19173188, 19173189, Exp 08/19; 19173852, 19173878, 19173893, Exp 10/19; 19174318, 19174341, Exp 11/19.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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