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,

FDA recall notice · announced November 16, 2016 · Sandoz

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.

Notes

Distribution: TN
Lot/code information: 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.
Quantity: 42,740 cartons (24 count carton from 7 total lots)
Status: Terminated
Products in this recall event:
- 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, C (D-0133-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.