Recalls / Class II
Class IID-0649-2021
Product
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03
- Brand name
- Buprenorphine And Naloxone
- Generic name
- Buprenorphine And Naloxone
- Active ingredients
- Buprenorphine Hydrochloride, Naloxone Hydrochloride Dihydrate
- Route
- Buccal, Sublingual
- NDCs
- 47781-355, 47781-356, 47781-357, 47781-358
- FDA application
- ANDA205954
- Affected lot / code info
- Lot #: 36924, Exp 6/2021
Why it was recalled
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Recalling firm
- Firm
- Alvogen, Inc
- Manufacturer
- Alvogen Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 44 Whippany Rd Ste 107, Morristown, New Jersey 07960-4558
Distribution
- Quantity
- 9,696 cartons
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2021-02-26
- FDA classified
- 2021-07-02
- Posted by FDA
- 2021-07-14
- Terminated
- 2022-02-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0649-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.