Why it was recalled
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Product description
dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1
Lot numbers, UPCs & expiration codes
Lot# 36-262537, Exp 9/19/2023. ;
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-1137-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 17, 2023
- FDA report date
- Sep 6, 2023
- Quantity
- 235 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-1137-2023, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 92898
- Address
- 2200 S 43rd Ave
- Code information
- Lot# 36-262537, Exp 9/19/2023. ;
- Postal code
- 85043-3909
- Report date
- Sep 6, 2023
- Product type
- Drugs
- Recall number
- D-1137-2023
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Product quantity
- 235 bags
- Termination date
- Mar 27, 2025
- Reason for recall
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 17, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 28, 2023