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FDA (Device enforcement)Recalled 2022-05-25class ii

Mckesson Medical-Surgical Inc. Corporate Office: a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number: USSCupA-12BUP300. b. Alcon Contact Lens Sol

Is my product affected?

a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number: USSCupA-12BUP300. b. Alcon Contact Lens Solution Opti Free Replenish 4 oz. Solution Model Number: 00065035604 Model Number: USSCupA-12BUP300. c. Alcon Contact Lens Solution Opti Free Replenish

  • UPC 00047113609126
  • UPC 20300650358204
  • UPC 00300650356350
  • UPC 20300650356354
  • UPC 00300650356107
  • UPC 20300650357207
  • UPC 00300651356380
  • UPC 20300650357399

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

What happened

McKesson Medical-Surgical Inc. is recalling Alcon Clear Care Contact Lens Solution in 12 oz. bottles due to temperature excursions at a facility between June and August 2021 prior to delivery. Exposure to higher temperatures during this period may have reduced the product's effectiveness. The recall affects all lots received between June 1, 2021 and September 30, 2021, and was distributed nationwide.

The affected products include multiple models with specific lot codes and GTINs received between July 4, 2021 and September 30, 2021. The source document does not specify a remedy or action for affected consumers.

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

Hazard

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Details from the source

Reason for recall: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. Distribution: US Nationwide Quantity: a. 3 b. 91 c. 45 d. 2 Lot/code info: a. GTIN: 00047113609126 EA; 20300650358204 CS. All lots received between 7/4/21-9/30/21. b. GTIN: 00300650356350 EA; 20300650356354 CS All lots received between 7/4/21-9/30/21. c. GTIN: 00300650356107 EA; 20300650357207 CS All lots received between 7/4/21-9/30/21. d. GTIN: 00300651356380 EA, 20300650357399 CS All lots received between 7/4/21-9/30/21

Source

Official record: FDA (Device enforcement) ↗

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

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