Drug recall D-0606-2018
Product
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.
Reason for recall
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.
Lots and codes
Lot #: 19172776, 19172794, Exp 07/19; 19173111, 19173186, 19173188, 19173189, Exp 08/19; 19173852, 19173878, 19173893, Exp 10/19; 19174318, 19174341, Exp 11/19.
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- 109,080 Bottles
- Distribution
- Nationwide in the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 19, 2018
- Terminated
- December 16, 2019
Related products
- Indomethacin – drug information
- NDC 68462-406 Indomethacin · Indomethacin 25 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-302 Indomethacin · Indomethacin 50 mg/1 · Glenmark Pharmaceuticals Inc., USA