Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), pa...

FDA Drug Recall #D-0481-2017 — Class II — February 2, 2017

Recall Summary

Recall Number D-0481-2017
Classification Class II — Moderate risk
Date Initiated February 2, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Sandoz Inc
Location Princeton, NJ
Product Type Drugs
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

Lot / Code Information

Lot #: 6323Q11, 6328Q11, Exp 06/19; 6355Q11, Exp 07/19

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Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.