Drug Enforcement D-0249-2025

Failed Dissolution Specifications

Status

Ongoing

Classification

Class II

Report Date

March 12, 2025

Termination Date

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Product Information

Product description
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01
Product quantity
9840 bottles
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide within in the USA.

Location & Firm

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address
2 Independence Way

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0249-2025
Event ID
96242
Recall initiation date
February 6, 2025
Center classification date
March 3, 2025
Code info
Lot #: AD16615, Exp. Date 07/2025
More code info
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