# FDA recall D-249-2013

> **Teva Pharmaceuticals USA, Inc.** · Class II · drug recall initiated 2012-12-05.

## Product

Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box, Marketed by: TEVA Neuroscience, Inc., Kansas City, MO  64131; Distributed by: TEVA Pharmaceuticals USA, Inc., North Wales, PA  19454, NDC 68546-317-30

## Reason for recall

Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-249-2013
- **Recalling firm:** Teva Pharmaceuticals USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-12-05
- **Report date:** 2013-04-24
- **Termination date:** 2013-07-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sellersville, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-249-2013

## Citation

> AI Analytics. FDA recall D-249-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-249-2013. Source: US FDA. Licensed CC0.

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