# FDA recall D-0845-2018

> **RIJ Pharmaceutical LLC** · Class II · drug recall initiated 2018-05-07.

## Product

RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL), RIJ PHARMACETUICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 53807-129-04, UPC 353807129048

## Reason for recall

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0845-2018
- **Recalling firm:** RIJ Pharmaceutical LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-05-07
- **Report date:** 2018-06-20
- **Termination date:** 2023-04-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0845-2018

## Citation

> AI Analytics. FDA recall D-0845-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0845-2018. Source: US FDA. Licensed CC0.

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