# FDA recall D-0022-2015

> **Gyma Laboratories Of Amer,Inc** · Class II · drug recall initiated 2014-07-09.

## Product

Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004

## Reason for recall

cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0022-2015
- **Recalling firm:** Gyma Laboratories Of Amer,Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-07-09
- **Report date:** 2014-10-22
- **Termination date:** 2018-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Westbury, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0022-2015

## Citation

> AI Analytics. FDA recall D-0022-2015. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0022-2015. Source: US FDA. Licensed CC0.

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