# FDA recall D-0213-2017

> **VIRTUS PHARMACEUTICALS OPCO II L** · Class I · drug recall initiated 2016-09-02.

## Product

Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN  37217, NDC 76439-307-10.

## Reason for recall

Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0213-2017
- **Recalling firm:** VIRTUS PHARMACEUTICALS OPCO II L
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-09-02
- **Report date:** 2016-12-28
- **Termination date:** 2019-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Nashville, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0213-2017

## Citation

> AI Analytics. FDA recall D-0213-2017. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0213-2017. Source: US FDA. Licensed CC0.

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