D-0649-2021 Class II Terminated
FDA drug recall D-0649-2021 was initiated by Alvogen, Inc on February 26, 2021 and is designated Class II. Reason for recall: Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low) The recall status is terminated (terminated February 16, 2022). Affected quantity: 9,696 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- July 14, 2021
- Initiation Date
- February 26, 2021
- Termination Date
- February 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,696 cartons
Product Description
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
Reason for Recall
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Distribution Pattern
USA nationwide.
Code Information
Lot #: 36924, Exp 6/2021