# FDA recall D-0880-2022

> **American Health Packaging** · Class III · drug recall initiated 2022-05-03.

## Product

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217,  NDC: 68084-446-01

## Reason for recall

Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0880-2022
- **Recalling firm:** American Health Packaging
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-05-03
- **Report date:** 2022-05-25
- **Termination date:** 2023-09-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0880-2022

## Citation

> AI Analytics. FDA recall D-0880-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0880-2022. Source: US FDA. Licensed CC0.

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