Drug 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
D-0068-2023
Product summary
- Event
- Event 91146
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14, 064 (30 sachets in a carton)
- Official record key
drug-enforcement:D-0068-2023
Official wording
Reason: Discoloration
Code information: Lot #: MHC1317A, Exp 07/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Unknown
Discoloration