Drug Enforcement D-0068-2023

Discoloration

Status

Terminated

Classification

Class II

Report Date

November 30, 2022

Termination Date

September 13, 2023

Product Information

Product description
Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (sesquihydrate), Rx Only, distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, NDC 62756-071-60
Product quantity
14, 064 (30 sachets in a carton)
Reason for recall
Discoloration
Recall initiation reason
—
Initial firm notification
N/A
Distribution pattern
Nationwide in the USA.

Location & Firm

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

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

Codes & Dates

Recall number
D-0068-2023
Event ID
91146
Recall initiation date
July 25, 2022
Center classification date
November 22, 2022
Code info
Lot #: MHC1317A, Exp 07/2023
More code info
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