FDA-Drug2022-11-30Class II
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
Hazard
Discoloration
Sold states
Nationwide in the USA.
Affected count
14, 064 (30 sachets in a carton)
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0068-2023More SUN PHARMACEUTICAL INDUSTRIES INC recalls
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