# FDA recall D-1568-2014

> **Pharmakon Pharmaceuticals** · Class I · drug recall initiated 2014-04-21.

## Product

Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only.  Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN.  NDC: 45183-0105-78.

## Reason for recall

Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

## Distribution

United States: TX, IL, MD, IN

## Key facts

- **Recall number:** D-1568-2014
- **Recalling firm:** Pharmakon Pharmaceuticals
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-04-21
- **Report date:** 2014-09-03
- **Termination date:** 2014-12-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Noblesville, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1568-2014

## Citation

> AI Analytics. FDA recall D-1568-2014. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-1568-2014. Source: US FDA. Licensed CC0.

---

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