PlainRecalls
FDA Drug Moderate Class II Terminated

Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Reported: August 15, 2018 Initiated: May 17, 2018 #D-1063-2018

Product Description

Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Reason for Recall

Lack of sterility assurance.

Details

Units Affected
300 2-ml syringes
Distribution
Texas
Location
Dallas, TX

Frequently Asked Questions

What product was recalled?
Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247. Recalled by Guardian Pharmacy Services. Units affected: 300 2-ml syringes.
Why was this product recalled?
Lack of sterility assurance.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 15, 2018. Severity: Moderate. Recall number: D-1063-2018.