|
| | | | | | | | | | | | | | | Ranier's Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA. Administration of a non-sterile product that is intended to be sterile by subcutaneous, intramuscular, intravenous or ocular routes of administration may result in a site-specific or systemic infection which in turn may result in hospitalization, significant morbidity, organ damage, or a fatal outcome. The pharmacy has not received any reports of patient complaints or adverse events related to this recall. To date, FDA is not aware of any adverse events associated with the use of compounded drug products from the pharmacy. |
| | | | | | | | | | ** If you did not subscribe to the FDA Recalls, Market Withdrawals and Safety Alerts subscription you may unsubscribe from this list.
For additional information pertaining to this message, please click the link at the beginning of this bulletin. |
| | | |
|
|
Comments
Post a Comment