FDA Recall D-0088-2024

AbbVie Inc. · North Chicago, IL

Class III Ongoing 940 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

Product

Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11

Lot / code: Lot # 1187435 exp date: 02/2024

Quantity: 864 cartons

Reason for recall

Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.

Recall record

Recall number: D-0088-2024
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed in the US. No government or foreign consignees.
Recall initiated: 2023-10-17
Classified by FDA Center: 2023-11-05
FDA published: 2023-11-15
Recalling firm: AbbVie Inc.
Firm location: North Chicago, IL

Drug identification

Brand name(s): SYNTHROID
Generic name(s): LEVOTHYROXINE SODIUM
Manufacturer(s): AbbVie Inc.
NDC(s): 0074-3727, 0074-4341, 0074-4552, 0074-5182, 0074-6594, 0074-6624, 0074-9296, 0074-7068, 0074-7069, 0074-7070, 0074-7148, 0074-7149
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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