# FDA recall D-1420-2012

> **JHP Pharmaceuticals, LLC** · Class III · drug recall initiated 2012-06-05.

## Product

Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02

## Reason for recall

Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1420-2012
- **Recalling firm:** JHP Pharmaceuticals, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-06-05
- **Report date:** 2012-07-25
- **Termination date:** 2012-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1420-2012

## Citation

> AI Analytics. FDA recall D-1420-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1420-2012. Source: US FDA. Licensed CC0.

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