# FDA recall D-0533-2022

> **ULTRAtab Laboratories, Inc.** · Class II · drug recall initiated 2022-01-26.

## Product

Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00

## Reason for recall

CGMP Deviations

## Distribution

Bulk product was distributed to 3 distributors who may have distributed finished product.

## Key facts

- **Recall number:** D-0533-2022
- **Recalling firm:** ULTRAtab Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-01-26
- **Report date:** 2022-02-16
- **Termination date:** 2025-01-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0533-2022

## Citation

> AI Analytics. FDA recall D-0533-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0533-2022. Source: US FDA. Licensed CC0.

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