FDA recall D-0004-2023

Product

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.

Reason for recall

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-06-21

Report date

2022-10-05

Termination date

2023-08-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0004-2023