← FDA ENFORCEMENT
D-0438-2024Class II

NATCO Pharma Limited

Recalling firm
NATCO Pharma Limited
Product type
Drug
Status
Terminated
Report date
2024-04-17
Distribution
Nationwide in the US
Firm state
N/A
Product quantity
30 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations

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

Code / lot info

Lot#: 411988, Exp date: 05/31/2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.