Drug recall: Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie

FDA enforcement event 87016 · Class II · initiated 30 Dec 2020 · status Terminated · terminated 21 Jun 2023

DrugVoluntary: Firm initiated1 product recordMadison, NJ

FDA enforcement event 87016 is a drug recall by Allergan, PLC. of Madison, NJ, initiated 30 Dec 2020 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 64% of the 342 drug enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 21 Jun 2023. Initiation: voluntary: firm initiated. Allergan, PLC. has 8 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Allergan, PLC., Madison, NJ.

Reason for recall

"Labeling: Missing instructions for use insert"

Distribution

"Nationwide."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0233-2021	Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, NJ 07940 UPC 3 00236 63410 0, NDC 0023-6634-10.	100,634 bottles	Class II	Terminated	27 Jan 2021

Context

64%of 2020 drug events are Class II342 events that year

1product record in this eventfirm median: 1

8events on this register for the firm

Other enforcement events for Allergan, PLC.

Initiated	Product (first record)	Type	Class	Records
29 Dec 2020	REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile	Device	Class II	1
6 Jul 2020	Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, C	Drug	Class III	2
6 Nov 2019	Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/	Device	Class III	4
30 Oct 2019	XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model	Device	Class II	1
24 Jul 2019	Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Sty	Device	Class I	15
20 Dec 2018	OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only,	Drug	Class II	1
24 May 2018	Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: Al	Drug	Class I	1

All 8 events for Allergan, PLC.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Labeling: Missing instructions for use insert"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 21 Jun 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.