Medications & Supplements/Prescription Drugs

L. Perrigo Company: Scopolamine Transdermal Patches Recalled for Defective Delivery System

Agency Publication Date: May 15, 2018

Summary

L. Perrigo Company is recalling approximately 569,520 cartons of Scopolamine Transdermal Therapeutic Systems (1 mg/3 days) because of a defect in the drug delivery system. This prescription medication, which is used to prevent nausea and vomiting from motion sickness or surgery, includes the generic name scopolamine and was distributed in 4-count, 10-count, and 24-count packages. Consumers should consult with their healthcare provider or pharmacist regarding the effectiveness of their patches and to arrange for a replacement or refund. This nationwide recall affects products manufactured by Aveva Drug Delivery Systems and distributed by Perrigo.

Risk

A defective delivery system means the patch may not provide the correct amount of medication as intended, which could lead to a lack of efficacy in preventing nausea or potentially improper dosing.

What You Should Do

Check your medication packaging for Scopolamine Transdermal Therapeutic System (1 mg/3 days) to see if it matches the following NDC numbers: 45802-580-84 (4-count), 45802-580-46 (10-count), or 45802-580-62 (24-count).
If you have a 4-count pack (NDC 45802-580-84), check for lot numbers 46397 or 46457 (Exp 03/19); 46621 (Exp 04/19); 46894, 46904, or 46905 (Exp 06/19); 47133 (Exp 07/19); 47153 (Exp 08/19); or 47154, 47213, or 47214 (Exp 09/19).
If you have a 10-count pack (NDC 45802-580-46), check for lot numbers 46695 (Exp 04/19); 46994 or 47012 (Exp 07/19); or 47322 (Exp 10/19).
If you have a 24-count pack (NDC 45802-580-62), check for lot numbers 46822 (Exp 05/19) or 47155 and 47212 (Exp 09/19).
Contact your healthcare provider or pharmacist immediately to discuss using an alternative lot or medication, especially if you rely on this for post-operative care or severe motion sickness.
Return any unused patches from the affected lots to your pharmacy to receive a refund.
Contact L. Perrigo Company at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information regarding this recall.
For additional questions or to report side effects, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Contact healthcare provider and return product to pharmacy.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Scopolamine Transdermal Therapeutic System, 1 mg/3 days (4-count)

Model:

NDC 45802-580-84

Lot Numbers:

46397 (Exp 03/19)

46457 (Exp 03/19)

46621 (Exp 04/19)

46894 (Exp 06/19)

46904 (Exp 06/19)

46905 (Exp 06/19)

47133 (Exp 07/19)

47153 (Exp 08/19)

47154 (Exp 09/19)

47213 (Exp 09/19)

47214 (Exp 09/19)

Date Ranges: Expiration March 2019, Expiration April 2019, Expiration June 2019, Expiration July 2019, Expiration August 2019, Expiration September 2019

Product: Scopolamine Transdermal Therapeutic System, 1 mg/3 days (10-count)

Model:

NDC 45802-580-46

Lot Numbers:

46695 (Exp 04/19)

46994 (Exp 07/19)

47012 (Exp 07/19)

47322 (Exp 10/19)

Date Ranges: Expiration April 2019, Expiration July 2019, Expiration October 2019

Product: Scopolamine Transdermal Therapeutic System, 1 mg/3 days (24-count)

Model:

NDC 45802-580-62

Lot Numbers:

46822 (Exp 05/19)

47155 (Exp 09/19)

47212 (Exp 09/19)

Date Ranges: Expiration May 2019, Expiration September 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80041

Status: Resolved

Manufacturer: L. Perrigo Company

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 569,520 cartons

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication packaging for Scopolamine Transdermal Therapeutic System (1 mg/3 days) to see if it matches the following NDC numbers: 45802-580-84 (4-count), 45802-580-46 (10-count), or 45802-580-62 (24-count).

If you have a 4-count pack (NDC 45802-580-84), check for lot numbers 46397 or 46457 (Exp 03/19); 46621 (Exp 04/19); 46894, 46904, or 46905 (Exp 06/19); 47133 (Exp 07/19); 47153 (Exp 08/19); or 47154, 47213, or 47214 (Exp 09/19).

If you have a 10-count pack (NDC 45802-580-46), check for lot numbers 46695 (Exp 04/19); 46994 or 47012 (Exp 07/19); or 47322 (Exp 10/19).

If you have a 24-count pack (NDC 45802-580-62), check for lot numbers 46822 (Exp 05/19) or 47155 and 47212 (Exp 09/19).

Contact your healthcare provider or pharmacist immediately to discuss using an alternative lot or medication, especially if you rely on this for post-operative care or severe motion sickness.

Return any unused patches from the affected lots to your pharmacy to receive a refund.

Contact L. Perrigo Company at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information regarding this recall.

For additional questions or to report side effects, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Scopolamine Transdermal Therapeutic System, 1 mg/3 days (4-count)

Model:

NDC 45802-580-84

Lot Numbers:

46397 (Exp 03/19)

46457 (Exp 03/19)

46621 (Exp 04/19)

46894 (Exp 06/19)

46904 (Exp 06/19)

46905 (Exp 06/19)

47133 (Exp 07/19)

47153 (Exp 08/19)

47154 (Exp 09/19)

47213 (Exp 09/19)

47214 (Exp 09/19)

Date Ranges: Expiration March 2019, Expiration April 2019, Expiration June 2019, Expiration July 2019, Expiration August 2019, Expiration September 2019

Product: Scopolamine Transdermal Therapeutic System, 1 mg/3 days (10-count)

Model:

NDC 45802-580-46

Lot Numbers:

46695 (Exp 04/19)

46994 (Exp 07/19)

47012 (Exp 07/19)

47322 (Exp 10/19)

Date Ranges: Expiration April 2019, Expiration July 2019, Expiration October 2019

Product: Scopolamine Transdermal Therapeutic System, 1 mg/3 days (24-count)

Model:

NDC 45802-580-62

Lot Numbers:

46822 (Exp 05/19)

47155 (Exp 09/19)

47212 (Exp 09/19)

Date Ranges: Expiration May 2019, Expiration September 2019