Class II · ModerateRecall completed
Transderm Scop (scopolamine) Transdermal System
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberNDC [redacted-phone] (24 ct. carton) and NDC [redacted-phone] (patch); Lot #'s FV5908 and FX1520 both with expiry 06/2018; GB4910 and GC4210 both with expiry 09/2018; GE1927 with expiry 12/2018; GF7017 with expiry 01/2019 and GH8065 with expiry 02/2019.
Where it was soldTN
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byAlza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054
| Distributed by / for | Sandoz Inc |
Show the full FDA record
| Full product label | Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054 |
| Recalling firm | Sandoz Inc |
| Distribution | TN |
| Quantity | 42,740 cartons (24 count carton from 7 total lots) |
| Recall initiated | 2016-08-24 |
| Report date | 2016-11-16 |
| Recall completed | 2017-06-07 |
| Recall number | D-0133-2017 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.