FDA recall D-009-2014

Product

Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43

Reason for recall

Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.

Distribution

KY & TN

Key facts

Status

Terminated

Initiation date

2013-09-16

Report date

2013-11-27

Termination date

2014-05-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Seymour, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-009-2014