# FDA recall D-1311-2020

> **SCA Pharmaceuticals** · Class II · drug recall initiated 2020-06-16.

## Product

Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46

## Reason for recall

Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.

## Distribution

Product was distributed to hospitals in PA and CA.

## Key facts

- **Recall number:** D-1311-2020
- **Recalling firm:** SCA Pharmaceuticals
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-06-16
- **Report date:** 2020-06-24
- **Termination date:** 2021-03-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Windsor, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1311-2020

## Citation

> AI Analytics. FDA recall D-1311-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1311-2020. Source: US FDA. Licensed CC0.

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