Why it was recalled
Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.
Product description
Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patches per carton (NDC 66758-208-54), Rx Only, Manufactured by ALZA Corporation, Vacaville, CA 95688 for Sandoz Inc., Princeton, NJ 08540.
Lot numbers, UPCs & expiration codes
Lot #: 6323Q11, 6328Q11, Exp 06/19; 6355Q11, Exp 07/19
Where it was sold
Nationwide in the USA and Puerto Rico
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-0481-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 2, 2017
- FDA report date
- Mar 1, 2017
- Quantity
- 157,922 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-0481-2017, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76435
- Address
- 100 College Rd W
- Code information
- Lot #: 6323Q11, 6328Q11, Exp 06/19; 6355Q11, Exp 07/19
- Postal code
- 08540-6604
- Report date
- Mar 1, 2017
- Product type
- Drugs
- Recall number
- D-0481-2017
- Classification
- Class II
- Recalling firm
- Sandoz Inc
- Product quantity
- 157,922 cartons
- Termination date
- Oct 24, 2017
- Reason for recall
- Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patches per carton (NDC 66758-208-54), Rx Only, Manufactured by ALZA Corporation, Vacaville, CA 95688 for Sandoz Inc., Princeton, NJ 08540.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Feb 2, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 17, 2017