D-0606-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 4, 2018
- Initiation Date
- March 19, 2018
- Termination Date
- December 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 109,080 Bottles
Product Description
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.
Distribution Pattern
Nationwide in the United States.
Code Information
Lot #: 19172776, 19172794, Exp 07/19; 19173111, 19173186, 19173188, 19173189, Exp 08/19; 19173852, 19173878, 19173893, Exp 10/19; 19174318, 19174341, Exp 11/19.