# FDA recall D-1493-2022

> **Plastikon Healthcare LLC** · Class II · drug recall initiated 2022-06-07.

## Product

CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry,  (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0

## Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-1493-2022
- **Recalling firm:** Plastikon Healthcare LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-06-07
- **Report date:** 2022-09-14
- **Termination date:** 2025-06-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lawrence, KS, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1493-2022

## Citation

> AI Analytics. FDA recall D-1493-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1493-2022. Source: US FDA. Licensed CC0.

---

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