First Aid Antiseptic Ointment Recalled for Mislabeled Inactive Ingredients

Plain-English summary

Rugby Laboratories is recalling First Aid Antiseptic (Povidone-Iodine 10%) ointment manufactured by Zhejiang Jingwei Pharmaceutical Co., Ltd. The product is a topical antiseptic available in 1 oz (28.4 g) tubes with NDC 0536-1271-80.

The recall was initiated because the inactive ingredients in the actual product differ from what is labeled on the product boxes and tubes. The labeled ingredients state "mineral oil, petrolatum," but the actual product contains polyethylene glycol 400 and polyethylene glycol 4000. This mislabeling could affect individuals who avoid or have sensitivities to these ingredients.

The affected product was distributed through one wholesaler in Ohio for nationwide distribution. A total of 295,164 tubes are affected, with lot numbers and expiration dates: Lot 220901 (Exp. 09/30/2024), Lot 230701 (Exp. 07/31/2026), Lot 230301 (Exp. 03/31/2026), Lot 230401 (Exp. 04/30/2026), Lot 230501 (Exp. 05/31/2026), Lot 230801 (Exp. 08/31/2026), Lot 240301 (Exp. 03/31/2027), and Lot 240501 (Exp. 04/30/2027).

Consumers should stop using this product if they have sensitivities to polyethylene glycol or prefer to avoid it. Contact Rugby Laboratories or the FDA if you have questions or believe you have been affected by this recall.

The recalled product

Product

FIRST AID ANTISEPTIC (POVIDONE-IODINE)

Brand

FIRST AID ANTISEPTIC

Manufacturer

Zhejiang Jingwei Pharmaceutical Co., Ltd.

Category

Drug — Over-the-counter topical antiseptic

Hazard

• mis-labeling
• undeclared-ingredient

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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