FDA Drug recall D-0816-2018
Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84)
- FDA Drug
- Class II
- terminated
- Published 2018-05-23
On 2018-05-23 the FDA classified a Class II recall of Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84) by L Perrigo, citing defective delivery system.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0816-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-11 |
| Published | 2018-05-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | L Perrigo |
| Distribution | US |
Product
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
Defective delivery system
Identifiers
| ndc | 45802-580-84 |
|---|---|
| ndc | 45802-580-46 |
| ndc | 45802-580-62 |
| ndc | 45802-580-01 |
| code_info | 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;…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0816-2018%22
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