Why it was recalled
Defective delivery system
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide in the U.S.A.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0816-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 11, 2018
- FDA report date
- May 23, 2018
- Quantity
- 569,520 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- L. Perrigo Company
Original FDA data
Every field from FDA enforcement report D-0816-2018, exactly as published.
Show all FDA fields
- City
- Allegan
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 80041
- Address
- 515 Eastern Ave
- 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
- Postal code
- 49010-9070
- Report date
- May 23, 2018
- Product type
- Drugs
- Recall number
- D-0816-2018
- Classification
- Class II
- Recalling firm
- L. Perrigo Company
- Product quantity
- 569,520 cartons
- Termination date
- Sep 28, 2020
- Reason for recall
- Defective delivery system
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the U.S.A.
- Recall initiation date
- May 11, 2018
- Initial firm notification
- Letter
- Center classification date
- May 15, 2018