Reported May 31, 2023 · Terminated
Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only,…
Teva Pharmaceuticals USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA Inc · 400 Interpace Pkwy Bldg A · Parsippany, NJ · 07054-1120
Is this the product you have?
- Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only
- Distributed byMayne Pharma, Greenville, NC 27834, NDC 51862-634-28
- Lot codes and dates
Lot# 42617828Exp 06/2023100020465Exp 01/2024
- Amount recalled
- 438
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Labeling: Incorrect or Missing Package Insert
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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