# FDA recall D-0075-2022

> **Ultra Seal Corporation** · Class III · drug recall initiated 2021-10-13.

## Product

Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)

## Reason for recall

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0075-2022
- **Recalling firm:** Ultra Seal Corporation
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-10-13
- **Report date:** 2021-11-03
- **Termination date:** 2022-03-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0075-2022

## Citation

> AI Analytics. FDA recall D-0075-2022. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0075-2022. Source: US FDA. Licensed CC0.

---

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