# FDA recall D-0327-2022

> **ULTRAtab Laboratories, Inc.** · Class II · drug recall initiated 2021-11-29.

## Product

PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L

## Reason for recall

CGMP Deviations: failed stability results, inadequate laboratory investigations,

## Distribution

Product was distributed to one customer who may have further distributed the product.

## Key facts

- **Recall number:** D-0327-2022
- **Recalling firm:** ULTRAtab Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-11-29
- **Report date:** 2022-01-12
- **Termination date:** 2023-02-24

- **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-0327-2022

## Citation

> AI Analytics. FDA recall D-0327-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0327-2022. Source: US FDA. Licensed CC0.

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