Why it was recalled
Lack of Sterility Assurance.
Product description
Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-103-13
Lot numbers, UPCs & expiration codes
Lot #: 10084, BUD: 7/25/2017; 10137, BUD: 8/2/2017; 10252, BUD: 8/15/2017; 10271, BUD: 8/17/2017; 10350, BUD: 8/30/2017; 10491, BUD: 9/21/2017
Where it was sold
Nationwide within the US
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-1073-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 14, 2017
- FDA report date
- Aug 16, 2017
- Quantity
- 2761 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cantrell Drug Company
Original FDA data
Every field from FDA enforcement report D-1073-2017, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 77780
- Address
- 7321 Cantrell Rd
- Code information
- Lot #: 10084, BUD: 7/25/2017; 10137, BUD: 8/2/2017; 10252, BUD: 8/15/2017; 10271, BUD: 8/17/2017; 10350, BUD: 8/30/2017; 10491, BUD: 9/21/2017
- Postal code
- 72207-4144
- Report date
- Aug 16, 2017
- Product type
- Drugs
- Recall number
- D-1073-2017
- Classification
- Class II
- Recalling firm
- Cantrell Drug Company
- Product quantity
- 2761 bags
- Termination date
- Sep 16, 2020
- Reason for recall
- Lack of Sterility Assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-103-13
- Distribution pattern
- Nationwide within the US
- Recall initiation date
- Jul 14, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 9, 2017