Recall: D-0268-2023

Class II - Potentially Harmful

Class IIClassification

2023-01-31Initiated

TerminatedStatus

BIOCON PHARMA INCFirm

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

Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.