Recall: D-0004-2023

Class III - Minor Violations

Class IIIClassification

2022-06-21Initiated

TerminatedStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.