Drug Enforcement D-0268-2023

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

Status

Terminated

Classification

Class II

Report Date

February 15, 2023

Termination Date

June 21, 2024

Product Information

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.
Product quantity
3665 bottles
Reason for recall
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
BIOCON PHARMA INC
Address
485 HWY 1 (S)

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0268-2023
Event ID
91577
Recall initiation date
January 31, 2023
Center classification date
February 14, 2023
Code info
Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025
More code info
—