FDAClass IIJune 2, 2021

Siladryl 12.5/5ml recall: CGMP Deviations

SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID

Why was Siladryl 12.5/5ml recalled?

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

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 distributed 02/23/2021 through 03/10/2021.

Product
SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID
Recalling firm
Cardinal Health Inc.
Quantity
78 bottles
Distribution
FL, GA, SC
Recall date
June 2, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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