Why it was recalled
Failed Tablet/Capsule Specifications: Tablet breakage
Product description
Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-408-01.
Lot numbers, UPCs & expiration codes
Lot #: 9570024, Exp. Jun-2019; 9570027, 9570029, Exp. Jul-2019; 7702088A, 7702089A, Exp. Aug-2019.
Where it was sold
Within the United States and Puerto Rico.
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-1017-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 18, 2018
- FDA report date
- Aug 8, 2018
- Quantity
- 11,652 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VENSUN PHARMACEUTICALS INC
Original FDA data
Every field from FDA enforcement report D-1017-2018, exactly as published.
Show all FDA fields
- City
- Yardley
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 80553
- Address
- 790 Township Line Rd
- Code information
- Lot #: 9570024, Exp. Jun-2019; 9570027, 9570029, Exp. Jul-2019; 7702088A, 7702089A, Exp. Aug-2019.
- Postal code
- 19067-4248
- Report date
- Aug 8, 2018
- Product type
- Drugs
- Recall number
- D-1017-2018
- Classification
- Class II
- Recalling firm
- VENSUN PHARMACEUTICALS INC
- Product quantity
- 11,652 bottles
- Termination date
- Apr 16, 2019
- Reason for recall
- Failed Tablet/Capsule Specifications: Tablet breakage
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-408-01.
- Distribution pattern
- Within the United States and Puerto Rico.
- Recall initiation date
- Jul 18, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 27, 2018