FDA-Drug2018-08-15Class II

Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Guardian Pharmacy Services
Hazard

Lack of sterility assurance.

Sold states
Texas
Affected count
4900 100-ml vials
Manufactured in
7920 Elmbrook Dr Ste 108, N/A, Dallas, TX, United States
Products
Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1052-2018

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