# FDA recall D-1523-2016

> **Pharmatech LLC** · Class II · drug recall initiated 2016-08-08.

## Product

Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz (120 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI  48150, NDC 0536-1025-47.

## Reason for recall

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1523-2016
- **Recalling firm:** Pharmatech LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-08-08
- **Report date:** 2016-10-05
- **Termination date:** 2024-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Davie, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1523-2016

## Citation

> AI Analytics. FDA recall D-1523-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1523-2016. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*