Class II
Terminated
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
This recall has been terminated (originally issued November 16, 2016).
- Company
- Sandoz Inc
- Recall Initiated
- August 24, 2016
- Posted
- November 16, 2016
- Recall Number
- D-0133-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 42,740 cartons (24 count carton from 7 total lots)
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Distribution
TN
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.
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