Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ
Summary
The FDA issued a Class II for Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufact by BIOCON PHARMA INC. Reason: Failed Impurities/Degradation Specifications: High Out Of Specification degradation results..
Details
Source
Drug Recall
External ID
D-0268-2023
Action Date
2023-02-15
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025
Quantity Affected: 3665 bottles
Reason for Recall
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-31
Company
ISELIN, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
BIOCON PHARMA INC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BIOCON PHARMA INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BIOCON PHARMA INC have FDA actions?
BIOCON PHARMA INC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0268-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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