Posaconazole Delayed-Release Tablets recall: Impurity Out of Spec
Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by…
Why was Posaconazole Delayed-Release Tablets recalled?
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025
- Product
- Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by…
- Recalling firm
- BIOCON PHARMA INC
- Quantity
- 3665 bottles
- Distribution
- Nationwide in the USA
- Recall date
- February 15, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)