BIOCON PHARMA INC: Drug Recall
Recall #D-0268-2023 · 01/31/2023
Class II: Risk
Recall Details
- Recall Number
- D-0268-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- BIOCON PHARMA INC
- Status
- Terminated
- Date Initiated
- 01/31/2023
- Location
- ISELIN, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3665 bottles
Reason for Recall
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Product Description
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.
Distribution Pattern
Nationwide in the USA
Other Recalls by BIOCON PHARMA INC
- Class II: Risk 03/17/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.