# FDA recall D-1055-2017

> **Time-Cap Laboratories, Inc.** · Class II · drug recall initiated 2017-06-16.

## Product

Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate, Verna, Goa-403 722, India, NDC 49483-603-50

## Reason for recall

Presence of  foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.

## Distribution

Nationwide U.S.A.

## Key facts

- **Recall number:** D-1055-2017
- **Recalling firm:** Time-Cap Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-06-16
- **Report date:** 2017-08-09
- **Termination date:** 2020-05-29

- **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-1055-2017

## Citation

> AI Analytics. FDA recall D-1055-2017. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-1055-2017. Source: US FDA. Licensed CC0.

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