# FDA recall D-0856-2020

> **Golden State Medical Supply Inc.** · Class III · drug recall initiated 2020-02-12.

## Product

TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012

## Reason for recall

Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0856-2020
- **Recalling firm:** Golden State Medical Supply Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-02-12
- **Report date:** 2020-03-04
- **Termination date:** 2023-04-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Camarillo, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0856-2020

## Citation

> AI Analytics. FDA recall D-0856-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0856-2020. Source: US FDA. Licensed CC0.

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