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 Pharmaceutic

FDA recall notice · announced November 30, 2022 · Sun Pharmaceutical Industries

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lot #: MHC1317A, Exp 07/2023
Quantity: 14, 064 (30 sachets in a carton)
Status: Terminated
Products in this recall event:
- 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 (se (D-0068-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.