# FDA recall D-1144-2023

> **Caplin Steriles Limited** · Class III · drug recall initiated 2023-08-14.

## Product

Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: Caplin Steriles Limited, India, NDC 72485-502-10

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

Nationwide in Tennessee

## Key facts

- **Recall number:** D-1144-2023
- **Recalling firm:** Caplin Steriles Limited
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-08-14
- **Report date:** 2023-09-13
- **Termination date:** 2025-09-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gummidipoondi, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1144-2023

## Citation

> AI Analytics. FDA recall D-1144-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-1144-2023. Source: US FDA. Licensed CC0.

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