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Two lots of a transdermal patch used to administer Fentanyl synthetic opioid have been recalled because the stamps inside some cartons may contain a different dosage than that shown in the cartons. This could have potentially life-threatening consequences.
Alvogen, Inc., is voluntarily recalling patches of transdermal patches of 12 mcg / h of fentanyl transdermal system. The company said that a small number of cartons contained patches of 50 μg / h.
The patches themselves indicate 50 mcg / h, but if a patient who bought the 12 mcg / h carton does not notice it and uses the 50 mcg / h patch, it could result in a "severe depression", according to the reminder.
The company said new users of patches, children and the elderly would potentially be at increased risk.
Alvorgen stated that it has received no reports of adverse effects resulting from this confusion.
The lots include:
- Lot 180060 fentanyl transdermal system, 12 mcg / h, expiry date 05/2020
- Lot 180073 fentanyl transdermal system, 12 mcg / h, expiry date 06/2020
Patients who have discovered that the box contains stamps containing the wrong dosage are advised to return it where they purchased it for replacement.
Questions regarding this recall should be directed to Alvogen at 866-770-3024 Monday to Friday from 9:00 am to 5:00 pm EDT or by sending an email to [email protected]
On April 21, 2019, Alvogen, Inc. voluntarily recalled two batches of transdermal patches of fentanyl transdermal system at 12 mcg / h.
Food and Drug Administration
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