# FDA recall D-0085-2019

> **Valeant Pharmaceuticals North America LLC** · Class II · drug recall initiated 2018-08-24.

## Product

Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875521011

## Reason for recall

CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.

## Distribution

Product was distributed throughout the United States

## Key facts

- **Recall number:** D-0085-2019
- **Recalling firm:** Valeant Pharmaceuticals North America LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-24
- **Report date:** 2018-10-31
- **Termination date:** 2020-03-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0085-2019

## Citation

> AI Analytics. FDA recall D-0085-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0085-2019. Source: US FDA. Licensed CC0.

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