PlainRecalls
FDA Drug Moderate Class II Terminated

Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Reported: August 15, 2018 Initiated: May 17, 2018 #D-1071-2018

Product Description

Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Reason for Recall

Lack of sterility assurance.

Details

Units Affected
2000 100-ml vials
Distribution
Texas
Location
Dallas, TX

Frequently Asked Questions

What product was recalled?
Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247. Recalled by Guardian Pharmacy Services. Units affected: 2000 100-ml vials.
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-1071-2018.