Drug product
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.
D-0481-2017
Product summary
- Firm
- Sandoz Inc
- Event
- Event 76435
- Status
- Terminated
- Classification
- Class II
- Quantity
- 157,922 cartons
- Official record key
drug-enforcement:D-0481-2017
Official wording
Reason: 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.
Code information: Lot #: 6323Q11, 6328Q11, Exp 06/19; 6355Q11, Exp 07/19
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect