Recalls / Class II
Class IID-0816-2018
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
- Brand name
- Scopolamine Transdermal System
- Generic name
- Scopolamine Transdermal System
- Active ingredient
- Scopolamine
- Route
- Transdermal
- NDC
- 45802-580
- FDA application
- ANDA078830
- Affected lot / 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; 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
Why it was recalled
Defective delivery system
Recalling firm
- Firm
- L. Perrigo Company
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 569,520 cartons
- Distribution pattern
- Nationwide in the U.S.A.
Timeline
- Recall initiated
- 2018-05-11
- FDA classified
- 2018-05-15
- Posted by FDA
- 2018-05-23
- Terminated
- 2020-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0816-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.