# FDA recall D-0053-2016

> **Rx PAK** · Class III · drug recall initiated 2015-10-13.

## Product

Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx only, Manufactured for Concordia Pharmaceuticals, Inc., St. Michael, Barbados BB11005, Manufactured by IriSys, LLC San Diego, CA 92121, Repackaged by: RxPak, Div. of McKesson, Memphis, TN 38141, NDC 59212-425-10

## Reason for recall

Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0053-2016
- **Recalling firm:** Rx PAK
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-10-13
- **Report date:** 2015-10-28
- **Termination date:** 2016-06-30

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0053-2016

## Citation

> AI Analytics. FDA recall D-0053-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0053-2016. Source: US FDA. Licensed CC0.

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