Allergan PLC REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Missing Instruction For Use insert.

Recommended Action

Per FDA guidance

On 12/29/2020, the firm sent an "URGENT DEVICE RECALL" to customers via overnight tracked mail informing them the affected lot is missing the instructions for use and safety information referenced on the carton. Customers are instructed to: 1. Quarantine the product that they have in their inventory 2. Carry out a physical count of the affected product and record the count on the enclosed Business Response Form (BRF). 3. Send the BRF to the Recalling Firm via email within five (5) business days of receipt. To ensure that the Recalling Firm is able to account for all recalled product, it is imperative that customers return the form. Return the BRF even if they have no recalled product to return. 4. Upon receipt of the BRF, the Recalling firm will issue a pre-paid return shipping label for return of the recalled product. 5. If customers have further distributed any of the affected product lot, the Recalling Firm is asking that customers notify these customers down to the Retail/Health Care Provider level. In the notification to their customers, they are asked to include the BRF, ACTIONS REQUIRED and CONTACT INFORMATION. 6. Do Not return any product lots that are not the subject of this recall. For questions contact or additional informaiton: Product Returns - Quality@allergan.com 862-261-7249 8am - 4:30pm EST Adverse Events - 800-678-1605, 8am 6pm EST Option 1 Product Complaints - 800-678-1605, 8am 5pm CST Option 3

Distribution

As reported by FDA

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