Drug Enforcement D-0036-2025

Failed Impurities/Degradation Specification

Status

Ongoing

Classification

Class II

Report Date

November 13, 2024

Termination Date

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Product Information

Product description
Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.
Product quantity
2,040 100-count bottles
Reason for recall
Failed Impurities/Degradation Specification
Recall initiation reason
—
Initial firm notification
N/A
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Dr. Reddy's Laboratories, Inc.
Address
107 College Rd E, N/A

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

Codes & Dates

Recall number
D-0036-2025
Event ID
95588
Recall initiation date
October 22, 2024
Center classification date
November 4, 2024
Code info
Lot# FG14062, Exp 10/31/2025
More code info
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