Recalls / Class II
Class IID-0133-2017
Product
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
- Affected lot / code info
- NDC 10019-553-02 (24 ct. carton) and NDC 10019-553-88 (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.
Why it was recalled
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 42,740 cartons (24 count carton from 7 total lots)
- Distribution pattern
- TN
Timeline
- Recall initiated
- 2016-08-24
- FDA classified
- 2016-11-09
- Posted by FDA
- 2016-11-16
- Terminated
- 2017-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0133-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.