Drug recall D-0068-2023

Class II Terminated reported Nov 30, 2022

Product

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

Reason for recall

Discoloration

Lots and codes

Lot #: MHC1317A, Exp 07/2023

Recall details

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
Quantity
14, 064 (30 sachets in a carton)
Distribution
Nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
July 25, 2022
Terminated
September 13, 2023

Related products