# FDA recall D-1418-2012

> **Meda Pharmaceuticals Inc.** · Class II · drug recall initiated 2011-10-17.

## Product

Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical LLC Marietta, GA 30062, NDC 68220-086-30

## Reason for recall

Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1418-2012
- **Recalling firm:** Meda Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2011-10-17
- **Report date:** 2012-07-25
- **Termination date:** 2017-02-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Somerset, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1418-2012

## Citation

> AI Analytics. FDA recall D-1418-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1418-2012. Source: US FDA. Licensed CC0.

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