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.
Reported: February 15, 2023 Initiated: January 31, 2023 #D-0268-2023
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.
Reason for Recall
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Details
- Recalling Firm
- BIOCON PHARMA INC
- Units Affected
- 3665 bottles
- Distribution
- Nationwide in the USA
- Location
- ISELIN, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by BIOCON PHARMA INC. Units affected: 3665 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 15, 2023. Severity: Moderate. Recall number: D-0268-2023.
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