Recall: D-0606-2018

Class III - Minor Violations

Class IIIClassification

2018-03-19Initiated

TerminatedStatus

Glenmark Pharmaceuticals Inc.,Firm

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

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

Nationwide in the United States.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.