SUN PHARMACEUTICAL INDUSTRIES INC: Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ
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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product
- Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-762-10
- Reason / hazard
- Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the United States
- Recall initiated
- 2026-05-22
- Code info
- Lot #: AD93852, Exp Date: 06/2027.
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Princeton
- State
- NJ
- Country
- United States
- Event id
- 99066
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