# FDA recall D-1094-2020

> **Dr. Reddy's Laboratories, Inc.** · Class I · drug recall initiated 2020-03-16.

## Product

Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ  08540.

## Reason for recall

Defective Container: Recall is due to breaking and shattering of ampules upon opening

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-1094-2020
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-03-16
- **Report date:** 2020-04-08
- **Termination date:** 2022-12-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1094-2020

## Citation

> AI Analytics. FDA recall D-1094-2020. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/D-1094-2020. Source: US FDA. Licensed CC0.

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