# FDA recall D-0237-2018

> **Marksans Pharma Inc.** · Class II · drug recall initiated 2018-01-09.

## Product

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-114-30.

## Reason for recall

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

## Distribution

Distributed to repackaging firms in NY who then distributed Nationwide in the USA.

## Key facts

- **Recall number:** D-0237-2018
- **Recalling firm:** Marksans Pharma Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-01-09
- **Report date:** 2018-01-31
- **Termination date:** 2020-05-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hauppauge, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0237-2018

## Citation

> AI Analytics. FDA recall D-0237-2018. Retrieved 2026-05-23 from https://api.ai-analytics.org/recall/D-0237-2018. Source: US FDA. Licensed CC0.

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