Drug Enforcement D-0438-2024

CGMP Deviations

Status

Ongoing

Classification

Class II

Report Date

April 17, 2024

Termination Date

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Product Information

Product description
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
Product quantity
30 bottles
Reason for recall
CGMP Deviations
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the US

Location & Firm

Recalling firm
NATCO Pharma Limited
Address
Pharma Division, Kothur Village, N/A

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0438-2024
Event ID
94296
Recall initiation date
March 27, 2024
Center classification date
April 5, 2024
Code info
Lot#: 411988, Exp date: 05/31/2025
More code info
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