Why it was recalled
Labeling: Label Mix-Up
Product description
Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 case of 10 mL Unit Dose Cups (NDC 69339-148-19) Rx Only, Dash Pharmaceuticals, Upper Saddle River, NJ 07458.
Lot numbers, UPCs & expiration codes
Lot #: a) 376908P40, Exp. Date 02/28/2023; b) 376908P100, Exp. Date 02/28/2023
Where it was sold
Nationwide within the United States
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-0749-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 11, 2022
- FDA report date
- Apr 13, 2022
- Quantity
- 45,940 Unit Dose Cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- DASH Pharmaceuticals LLC
Original FDA data
Every field from FDA enforcement report D-0749-2022, exactly as published.
Show all FDA fields
- City
- Upper Saddle River
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89814
- Address
- 2 Park Way
- Code information
- Lot #: a) 376908P40, Exp. Date 02/28/2023; b) 376908P100, Exp. Date 02/28/2023
- Postal code
- 07458-2345
- Report date
- Apr 13, 2022
- Product type
- Drugs
- Recall number
- D-0749-2022
- Classification
- Class II
- Recalling firm
- DASH Pharmaceuticals LLC
- Product quantity
- 45,940 Unit Dose Cups
- Termination date
- Feb 16, 2023
- Reason for recall
- Labeling: Label Mix-Up
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 case of 10 mL Unit Dose Cups (NDC 69339-148-19) Rx Only, Dash Pharmaceuticals, Upper Saddle River, NJ 07458.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Mar 11, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 6, 2022