# FDA recall D-0686-2018

> **Time-Cap Laboratories, Inc.** · Class II · drug recall initiated 2018-01-11.

## Product

Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53943-291-14), Brown, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256

## Reason for recall

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

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0686-2018
- **Recalling firm:** Time-Cap Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-01-11
- **Report date:** 2018-05-02
- **Termination date:** 2021-01-20

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0686-2018

## Citation

> AI Analytics. FDA recall D-0686-2018. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0686-2018. Source: US FDA. Licensed CC0.

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