# FDA recall D-0318-2024

> **NATCO Pharma Limited** · Class II · drug recall initiated 2024-02-01.

## Product

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

## 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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0318-2024
- **Recalling firm:** NATCO Pharma Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-02-01
- **Report date:** 2024-02-14
- **Termination date:** 2026-02-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rangareddy, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0318-2024

## Citation

> AI Analytics. FDA recall D-0318-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0318-2024. Source: US FDA. Licensed CC0.

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