Why it was recalled
Discoloration
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
Lot numbers, UPCs & expiration codes
Lot #: MHC1317A, Exp 07/2023
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0068-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 25, 2022
- FDA report date
- Nov 30, 2022
- Quantity
- 14, 064 (30 sachets in a carton)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0068-2023, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91146
- Address
- 2 Independence Way
- Code information
- Lot #: MHC1317A, Exp 07/2023
- Postal code
- 08540-6620
- Report date
- Nov 30, 2022
- Product type
- Drugs
- Recall number
- D-0068-2023
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 14, 064 (30 sachets in a carton)
- Termination date
- Sep 13, 2023
- Reason for recall
- Discoloration
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jul 25, 2022
- Center classification date
- Nov 22, 2022