D-0068-2023 Class II Terminated
FDA drug recall D-0068-2023 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Jul 25, 2022 and is designated Class II. Reason for recall: Discoloration The recall status is terminated (terminated Sep 13, 2023). Affected quantity: 14, 064 (30 sachets in a carton).
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 30, 2022
- Initiation Date
- Jul 25, 2022
- Termination Date
- Sep 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14, 064 (30 sachets in a carton)
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
Reason for Recall
Discoloration
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: MHC1317A, Exp 07/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0068-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026