D-0816-2018 Class II Terminated
FDA drug recall D-0816-2018 was initiated by L. Perrigo Company on May 11, 2018 and is designated Class II. Reason for recall: Defective delivery system The recall status is terminated (terminated Sep 28, 2020). Affected quantity: 569,520 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- May 23, 2018
- Initiation Date
- May 11, 2018
- Termination Date
- Sep 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 569,520 cartons
Product Description
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
Reason for Recall
Defective delivery system
Distribution Pattern
Nationwide in the U.S.A.
Code Information
Lot #: a) 46397, 46457 Exp 03/19; 46621, Exp 04/19; 46894, 46904, 46905, Exp 06/19; 47133, Exp 07/19; 47153, Exp 08/19; 47154, 47213, 47214, Exp 09/19; b) 46695, Exp 04/19; 46994, 47012, Exp 07/19; 47322 10/19; c) 46822, Exp 05/19 ; 47155, 47212, Exp 09/19
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0816-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026