Drug Enforcement D-0597-2024

Failed Dissolution Specifications

Status

Completed

Classification

Class II

Report Date

July 24, 2024

Termination Date

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Product Information

Product description
Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.
Product quantity
5752 bottles
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA and Puerto rico

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-0597-2024
Event ID
94950
Recall initiation date
July 9, 2024
Center classification date
July 12, 2024
Code info
Lot #s: 231067, 231069, Exp 04/30/2025
More code info
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