FDAClass IIOctober 24, 2018

Gibco GlutaMAX Supplement recall: Sterility Concern

Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061

Why was Gibco GlutaMAX Supplement recalled?

Leaky bottles due to a defect in the bottle cap compromising the sterility of the product

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?

Lot Number: 1967697 (UDI 10190302001823) Exp. Date: 30-Jun-2020

Product
Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
Recalling firm
Life Technologies, Corp.
Quantity
1912 units
Distribution
Nationwide: Foreign: Argentina Australia Canada China Great Britain Hong Kong India Japan Mexico Netherlands New Zealand Singapore South Korea Taiwan
Recall date
October 24, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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