D-0606-2018 Class III Terminated
FDA drug recall D-0606-2018 was initiated by Glenmark Pharmaceuticals Inc., USA on Mar 19, 2018 and is designated Class III. 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… The recall status is terminated (terminated Dec 16, 2019). Affected quantity: 109,080 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 4, 2018
- Initiation Date
- Mar 19, 2018
- Termination Date
- Dec 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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0606-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026