Recalls / Class III
Class IIID-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.
- Brand name
- Indomethacin
- Generic name
- Indomethacin
- Active ingredient
- Indomethacin
- Route
- Oral
- NDCs
- 68462-302, 68462-406
- FDA application
- ANDA091276
- Affected 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.
Why it was recalled
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.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 109,080 Bottles
- Distribution pattern
- Nationwide in the United States.
Timeline
- Recall initiated
- 2018-03-19
- FDA classified
- 2018-03-26
- Posted by FDA
- 2018-04-04
- Terminated
- 2019-12-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0606-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.