Recalls / Class II
Class IID-0068-2023
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
- Brand name
- Pantoprazole Sodium
- Generic name
- Pantoprazole Sodium
- Active ingredient
- Pantoprazole Sodium
- Route
- Oral
- NDC
- 62756-071
- FDA application
- ANDA213725
- Affected lot / code info
- Lot #: MHC1317A, Exp 07/2023
Why it was recalled
Discoloration
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 14, 064 (30 sachets in a carton)
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2022-07-25
- FDA classified
- 2022-11-22
- Posted by FDA
- 2022-11-30
- Terminated
- 2023-09-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0068-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.