# FDA recall D-1445-2014

> **Sandoz Inc** · Class III · drug recall initiated 2014-07-11.

## Product

Orphenadrine Citrate Extended Release Tablets, 100 mg  a)100-count bottle,  (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.

## Reason for recall

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1445-2014
- **Recalling firm:** Sandoz Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-07-11
- **Report date:** 2014-07-30
- **Termination date:** 2017-07-10

- **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-1445-2014

## Citation

> AI Analytics. FDA recall D-1445-2014. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1445-2014. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*