Why it was recalled
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Product description
PHENYLephrine, 10mg/250ml added to 0.9% sodium chloride, 40mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.
Lot numbers, UPCs & expiration codes
Lot: 36-239333, Exp. 7/11/2023; 36-240005, Exp. 7/13/2023; 36-240800, Exp. 7/17/2023; 36-241139, 36-241140, Exp. 7/19/2023; 36-241913, Exp.7/23/2023; 36-242557, 36-242560, Exp. 7/25/2023; 36-244880, 36-244883, 36-244884, 36-244885, Exp. 8/1/2023; 36-246717, 36-246718, 36-246719, 36-246720, Exp.8/6/2023; 36-247598, 36-247599, Exp. 8/9/2023; 36-247828, 36-247829, 36-247830, 36-247831, Exp. 8/10/2023; 36-249233, 36-249234, 36-249235, 36-249344, Exp. 8/17/2023; 36-255964, Exp. 9/10/2023
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-0960-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 14, 2023
- FDA report date
- Aug 9, 2023
- Quantity
- 7518 bag
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-0960-2023, 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: 36-239333, Exp. 7/11/2023; 36-240005, Exp. 7/13/2023; 36-240800, Exp. 7/17/2023; 36-241139, 36-241140, Exp. 7/19/2023; 36-241913, Exp.7/23/2023; 36-242557, 36-242560, Exp. 7/25/2023; 36-244880, 36-244883, 36-244884, 36-244885, Exp. 8/1/2023; 36-246717, 36-246718, 36-246719, 36-246720, Exp.8/6/2023; 36-247598, 36-247599, Exp. 8/9/2023; 36-247828, 36-247829, 36-247830, 36-247831, Exp. 8/10/2023; 36-249233, 36-249234, 36-249235, 36-249344, Exp. 8/17/2023; 36-255964, Exp. 9/10/2023
- Postal code
- 85043-3909
- Report date
- Aug 9, 2023
- Product type
- Drugs
- Recall number
- D-0960-2023
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Product quantity
- 7518 bag
- 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, 10mg/250ml added to 0.9% sodium chloride, 40mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 14, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 1, 2023