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Recall D-0438-2024

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

Recall D-0438-2024 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0438-2024
Event ID94296
DistributionNationwide in the US
Quantity30 bottles
Recall ReasonCGMP Deviations
Drug ClassificationClass II
Drug Code Info20240417
Recall Initiation Date20240327
Report Date20240417
Classification Date20240405
AddressPharma Division, Kothur Village
Rangareddy,  
India
Recalling FirmNATCO Pharma Limited
Initial Notification Letter
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