Drug Enforcement D-0529-2023

Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.

Status

Terminated

Classification

Class III

Report Date

April 19, 2023

Termination Date

October 31, 2023

Product Information

Product description
Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in 10 x 4 mL Single-dose Fliptop Vials per carton (NDC 47335-615-44); Rx only, Manufactured by: Gland Pharma Limited, Hyderabad-502307 India; Distributed by: Sun Phamaceutical Industries, Inc., Cranbury, NJ 08512.
Product quantity
16,450 vials
Reason for recall
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address
2 Independence Way, N/A

United States
Voluntary / Mandated
N/A
Status date
—

Codes & Dates

Recall number
D-0529-2023
Event ID
91983
Recall initiation date
March 29, 2023
Center classification date
April 10, 2023
Code info
Lot Number: G1510001, Exp 11/2023; G151002, Exp. 12/2023; and G151003, Exp 02/2024
More code info
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