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.
Check against the official notice below — it lists the full affected range.
Glenmark Pharmaceuticals Inc. is recalling approximately 109,080 bottles of Indomethacin Capsules USP, 50 mg across the United States due to incorrect dosage instructions on the label. The bottles are labeled with instructions to take "one or two capsules 2 or 3 times a day," when the correct dosage should be "one capsule 2 or 3 times a day." The affected medication was manufactured in India and distributed nationwide, with specific lot numbers and expiration dates ranging from July 2019 to November 2019.
The source does not specify a remedy or what an affected consumer should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Nationwide in the United States. Quantity: 109,080 Bottles Lot/code info: Lot #: 19172776, 19172794, Exp 07/19; 19173111, 19173186, 19173188, 19173189, Exp 08/19; 19173852, 19173878, 19173893, Exp 10/19; 19174318, 19174341, Exp 11/19.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.