FDA recall D-1363-2014

Product

Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratories Limited, India and Distributed by Major Pharmaceuticals, Livonia, MI --- NDC 0904-6235-61

Reason for recall

Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets

Distribution

IN

Key facts

Status

Terminated

Initiation date

2014-04-09

Report date

2014-06-18

Termination date

2017-01-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Earth City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1363-2014