Calcium Gluconate 2 recalled over sterility concerns

Recall date

September 10, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pharm D Solutions, LLC recalls Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2.5 Inhal Soln. NDC 69699-0908-10; c) Nebul…

Recall number

D-0149-2019

FDA classification

Class III

Brand / firm

Pharm D Solutions, LLC

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2.5 Inhal Soln. NDC 69699-0908-10; c) Nebulization Solution 2.5% Inhal. Soln NDC 69699-0908-10; d) Nebulization 250 mL 2.5% Inhal Soln NDC 69699-0908-25; e) Oral Spray 2.5% 2.5% Oral Soln NDC 69699-0917-60, Pharm D Solutions, Houston, Texas