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FDA (Drug enforcement)Recalled 2021-08-26closedclass ii

AVRIO HEALTH L.P: Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile Solution Avrio Health LP Stamford, CT 06901-3431 NDC 67618-153-01, NDC 67

Is my product affected?

Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile Solution Avrio Health LP Stamford, CT 06901-3431 NDC 67618-153-01, NDC 67618-153-03

  • Brand BETADINE

Check against the official notice below — it lists the full affected range.

What happened

Avrio Health L.P. has recalled Betadine Solution Swabstick Povidone-Iodine Solution USP 10% in both single and three-count packages distributed nationwide. The recall affects approximately 75,828 shippers due to the product being subpotent, meaning it contains less active ingredient than required. The affected products have multiple lot numbers with expiration dates ranging from September 2021 through March 2023.

The recall source does not specify what actions affected consumers should take regarding this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Subpotent Drug

Details from the source

Reason for recall: Subpotent Drug Distribution: Product was distributed nationwide. Quantity: 75,828 shippers Lot/code info: Lot # 11901232, Exp. Date 09/30/2021 11901549, Exp. Date 11/30/2021 12000585, Exp. Date 03/31/2022 12000964, Exp. Date 5/31/2022 12001457, Exp. Date 7/31/2022 12002142, Exp. Date 12/31/2022 12100407, Exp. Date 03/31/2023 11901231, Exp. Date 09/30/2021 11901548, Exp. Date 11/30/2021 12000584, Exp. Date 03/31/2022 12000963, Exp. Date 05/31/2022 12001185, Exp. Date 06/30/2022 12001456, Exp. Date 07/31/2022 12002150, Exp. Date 12/31/2022 12100406, Exp. Date 03/31/2023

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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