FDAClass IIFebruary 24, 2016

calcium elemental recall: Sterility Concern

calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

Why was calcium elemental recalled?

Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.

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?

All Lots

Product
calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Recalling firm
Abbott's Compounding Pharmacy, Inc.
Quantity
200 ml
Distribution
CA
Recall date
February 24, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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