AVEVA Drug Delivery Systems, Inc. recalls Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only,…
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Read the official notice →- Date
- 2023-03-22
- Country
- United States
- Brand
- AVEVA Drug Delivery Systems
- Product
- Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva…
- Classification
- Class III
- Units
- Nationwide
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
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FDA · DeviceAvanos Medical, Inc.US Nationwide distribution in the state of Oklahoma.Official notice → - US
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CGMP Deviations: Potential risk of Cross Contamination
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Pfizer Recalls Nurtec ODT Prescription Drugs Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
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