FDAClass IIINovember 7, 2018

Calcium Gluconate 2.5% a) recall: Sterility Concern

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.…

Why was Calcium Gluconate 2.5% a) recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots: a) 05072018:40 Discard by: 5/2/2019; b) 07262018:44 Discard by: 1/22/2019; c) 07122018:83 Discard by: 7/12/2019; d) 07262018:93 Discard by: 1/22/2019; e) 07262018:81 Discard by: 1/21/2019

Product
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.…
Recalling firm
Pharm D Solutions, LLC
Quantity
57 bottles; 2300 milliliters
Distribution
Nationwide
Recall date
November 7, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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