Drug Enforcement D-0005-2023

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

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Status

Terminated

Classification

Class III

Report Date

October 5, 2022

Termination Date

August 11, 2023

Product Information

Product description
Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, 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 63304-735-90.
Product quantity
8640 bottles
Reason for recall
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address
2 Independence Way, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0005-2023
Event ID
90891
Recall initiation date
June 21, 2022
Center classification date
October 6, 2022
Code info
Lot AC14304, Exp 12/2022.
More code info
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