FDA-Drug2023-02-15Class II
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.
BIOCON PHARMA INC
Hazard
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Sold states
Nationwide in the USA
Affected count
3665 bottles
Manufactured in
485 HWY 1 (S), ISELIN, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0268-2023Don't want to check this manually?
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