Why it was recalled
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Product description
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
TN
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-0133-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 24, 2016
- FDA report date
- Nov 16, 2016
- Quantity
- 42,740 cartons (24 count carton from 7 total lots)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-0133-2017, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75168
- Address
- 100 College Rd W
- 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.
- Postal code
- 08540-6604
- Report date
- Nov 16, 2016
- Product type
- Drugs
- Recall number
- D-0133-2017
- Classification
- Class II
- Recalling firm
- Sandoz Inc
- Product quantity
- 42,740 cartons (24 count carton from 7 total lots)
- Termination date
- Jun 7, 2017
- Reason for recall
- Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- TN
- Recall initiation date
- Aug 24, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 9, 2016