# FDA recall D-0012-2018

> **RXQ Compounding LLC** · Class II · drug recall initiated 2017-09-25.

## Product

methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC:  70731-0936-10

## Reason for recall

Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.

## Distribution

TX, LA, PA, MA, FL, and OH

## Key facts

- **Recall number:** D-0012-2018
- **Recalling firm:** RXQ Compounding LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-09-25
- **Report date:** 2017-10-25
- **Termination date:** 2017-12-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Athens, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0012-2018

## Citation

> AI Analytics. FDA recall D-0012-2018. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/D-0012-2018. Source: US FDA. Licensed CC0.

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