Medicine recalls
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| The United States: Teva Initiates Voluntary Nationwide Recall of Specific Lots of FENTANYL Buccal Tablets CII Due to a Labeling Error |
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The US Food and Drug Administration (FDA) announces that Teva Pharmaceuticals USA has initiated a voluntary nationwide recall of specific lots of various strengths of FENTANYL Buccal Tablets CII to the Consumer Level. Teva USA manufactured and labeled these product lots exclusively for Mayne Pharma Inc. under Mayne’s label. This recall has been initiated because safety updates were omitted in the Product Insert/Medication Guide (MG) that are provided with these recalled lots.
The main safety concern is a potential for incomplete information needed by health care providers and patients regarding safe use of the product. Not following, or not being aware of, the omitted safety updates in the Product Insert/Medication Guide (MG) could lead to life-threatening adverse events; although, based on a Health Hazard Assessment conducted by Teva, the likelihood of the harm occurrence is considered remote. To date, Teva has not received any complaints related to the product labeling. The affected products are:
NDC# 51862-634-28; strength 100mcg
NDC# 51862-635-28; strength 200mcg
NDC# 51862-636-28; strength 400mcg
NDC# 51862-637-28; strength 600mcg
NDC# 51862-638-28; strength 800mcg
For details of the affected batch numbers, please refer to the website in FDA.
Please refer to the following website in FDA for details:http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-initiates-voluntary-nationwide-recall-specific-lots-fentanyl-buccal-tablets-cii-due-labeling
In Hong Kong, Fentora Buccal Tablets 100mcg (HK-64082), Fentora Buccal Tablets 200mcg (HK-64078), Fentora Buccal Tablets 400mcg (HK-64080), Fentora Buccal Tablets 600mcg (HK-64081) and Fentora Buccal Tablets 800mcg (HK-64079) are pharmaceutical products registered by Teva Pharmaceutical Hong Kong O/B Teva Pharmaceutical Hong Kong Limited (Teva), and are prescription-only medicines. Teva has been contacted on the impact of the recall on the local market and result is pending.
Ends/ Saturday, Apr 29, 2023
Issued at HKT 12:00
As confirmed with Teva, the affected lots have not been imported into Hong Kong.
Content last updated: Tuesday, May 2, 2023
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