D-0481-2017 Class II Terminated
FDA drug recall D-0481-2017 was initiated by Sandoz Inc on February 2, 2017 and is designated Class II. 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 contai… The recall status is terminated (terminated October 24, 2017). Affected quantity: 157,922 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 1, 2017
- Initiation Date
- February 2, 2017
- Termination Date
- October 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 157,922 cartons
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.
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot #: 6323Q11, 6328Q11, Exp 06/19; 6355Q11, Exp 07/19