Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11.
FDA recall notice · announced February 15, 2023 · Biocon Pharma
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11.
Reason for recall
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Notes
Distribution: Nationwide in the USA
Lot/code information: Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025
Quantity: 3665 bottles
Status: Terminated
Products in this recall event:
- Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, (D-0268-2023)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.