Why it was recalled
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Product description
PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.
Lot numbers, UPCs & expiration codes
Lot:36-239194, 36-239195, Exp.7/10/2023; 36-240009, Exp. 7/13/2023; 36-240799, Exp.7/17/2023; 36-241147, 36-241148, Exp. 7/19/2023; 36-241740, 36-241741, Exp. 7/21/2023; 36-242562, Exp. 7/25/2023; 36-243531, Exp. 7/30/2023; 36-244886, 36-244961, Exp. 8/1/2023; 36-246713, 36-246714, 36-24671, 536-246716, Exp. 8/6/2023; 36-247344, 36-247345, 36-247347, 36-247348, 36-247349, 36-247350, Exp. 8/8/2023; 36-247823, 36-247824, 36-247825, 36-247826, Exp. 8/10/2023; 36-248356, 36-248358, Exp. 8/11/2023; 36-249226, Exp. 8/17/2023; 36-251966, Exp. 8/30/2023.
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-0961-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 14, 2023
- FDA report date
- Aug 9, 2023
- Quantity
- 8,363 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-0961-2023, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 92707
- Address
- 2200 S 43rd Ave
- Code information
- Lot:36-239194, 36-239195, Exp.7/10/2023; 36-240009, Exp. 7/13/2023; 36-240799, Exp.7/17/2023; 36-241147, 36-241148, Exp. 7/19/2023; 36-241740, 36-241741, Exp. 7/21/2023; 36-242562, Exp. 7/25/2023; 36-243531, Exp. 7/30/2023; 36-244886, 36-244961, Exp. 8/1/2023; 36-246713, 36-246714, 36-24671, 536-246716, Exp. 8/6/2023; 36-247344, 36-247345, 36-247347, 36-247348, 36-247349, 36-247350, Exp. 8/8/2023; 36-247823, 36-247824, 36-247825, 36-247826, Exp. 8/10/2023; 36-248356, 36-248358, Exp. 8/11/2023; 36-249226, Exp. 8/17/2023; 36-251966, Exp. 8/30/2023.
- Postal code
- 85043-3909
- Report date
- Aug 9, 2023
- Product type
- Drugs
- Recall number
- D-0961-2023
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Product quantity
- 8,363 bags
- Termination date
- Mar 28, 2025
- Reason for recall
- Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 14, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 1, 2023