Food, drugs, devices › L. Perrigo Company

Drug recall: Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46);

FDA enforcement event 80041 · Class II · initiated 11 May 2018 · status Terminated · terminated 28 Sep 2020

DrugVoluntary: Firm initiated1 product recordAllegan, MI

L. Perrigo Company (Allegan, MI) initiated this drug recall on 11 May 2018; FDA lists 1 product record under event 80041, classified Class II.

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. 60% of the 367 drug enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 28 Sep 2020. Initiation: voluntary: firm initiated. L. Perrigo Company 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

L. Perrigo Company, Allegan, MI.

Reason for recall

"Defective delivery system"

Distribution

"Nationwide in the U.S.A."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0816-2018	Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46); c) 24-count (NDC 45802-580-62), Rx only, Mfd. by: Aveva Drug Delivery Systems, A Nitto Denko Company, Miramar, FL 33025 Distributed by Perrigo, Allegan, MI 49010	569,520 cartons	Class II	Terminated	23 May 2018

Context

60%of 2018 drug events are Class II367 events that year

1product record in this eventfirm median: 1

8events on this register for the firm

Other enforcement events for L. Perrigo Company

Initiated	Product (first record)	Type	Class	Records
9 Feb 2023	Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b)150-count	Drug	Class II	13
6 Nov 2018	Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, OTC, [Healthy Accents brand NDC: 55316-014-	Drug	Class II	1
8 Nov 2017	Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper carton, Distrib	Drug	Class II	1
5 Jun 2017	Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two plastic 12FL OZ (355 mL) bottles connected by	Drug	Class III	1
1 Jun 2017	Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet per box, Distributed By Perrigo, Allegan, MI	Drug	Class II	1
13 Feb 2017	Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham, Israel, Distributed By Perrigo Alle	Drug	Class III	2
28 Dec 2016	Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel,	Drug	Class II	1

All 8 events for L. Perrigo Company

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Defective delivery system"

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 in the U.S.A."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 28 Sep 2020. "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.