Drug Enforcement D-0318-2024

CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.

Status

Ongoing

Classification

Class II

Report Date

February 14, 2024

Termination Date

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Product Information

Product description
Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count 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
4260 bottles
Reason for recall
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
NATCO Pharma Limited
Address
Pharma Division, Kothur Village

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0318-2024
Event ID
93868
Recall initiation date
February 1, 2024
Center classification date
February 8, 2024
Code info
Lot # 411987 Exp: 05/2025
More code info
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