Why it was recalled
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Product description
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
Lot numbers, UPCs & expiration codes
Lot: 36-239063, 36-239064, 36-239065, 36-239066, 36-239067, 36-23906, 736-239068, 36-239069, 36-239204, Exp. 7/10/2023; 36-239196, 36-239197, 36-239198, 36-239199, 36-239200, 36-239201, 36-239202, 36-239203, 36-239205, 36-239206, Exp. 7/11/2023; 36-239483, 36-239487, 36-239488, 36-239489, 36-239490, 36-239639, 36-239640, 36-239641, Exp. 7/12/2023; 36-239788, 36-239789,36-239790, 36-239793, 36-239797, 36-239798, Exp. 7/13/2023; 36-240139, 36-240140, 36-240141, 36-240142, 36-240143, Exp. 7/16/2023; 36-240319, 36-240320, 36-240321 ,36-240322, 36-240812, Exp. 7/17/2023; 36-241074, 36-241075, 36-241076, 36-241077, Exp. 7/18/2023; 36-241136, Exp. 7/19/2023; 36-241357, 36-241358, 36-241359, 36-241372, 36-241373, Exp. 7/20/2023; 36-241715, 36-241718, 36-241719, 36-241720, 36-241721, 36-241723, 36-241850, Exp. 7/21/2023; 36-241918, 36-241919, 36-241920, 36-242184, Exp. 7/23/2023; 36-241993, 36-241994, 36-241995, 36-241997, Exp. 7/24/2023; 36-242402, 36-242403, 36-242404, 36-242405, 36-242406, 36-242913, Exp. 7/25/2023; 36-242630, 36-242631, 36-242632, 36-242633, 36-242634, Exp. 7/26/2023; 36-242799, 36-242800, 36-242801, 36-242802, 36-242803, 36-242806, Exp. 7/27/2023; 36-243537, 36-243538, 36-243539, Exp. 7/30/2023; 36-243820, 36-243822, 36-244311, 36-243819, Exp. 7/31/2023; 36-244877, 36-244878, 36-244879, 36-245572, 36-245574, Exp. 8/1/2023; 36-245805, 36-246140, 36-246141, 36-246142, 36-246143, Exp. 8/2/2023; 36-246292, 36-246293, 36-246294, 36-246295, 36-246296, 36-246297, Exp. 8/3/2023; 36-246696, 36-246697, 36-246700, 36-246702, Exp. 8/6/2023; 36-246780, 36-246781, 36-246782, 36-246784, 36-247058, Exp. 8/7/2023; 36-248214, 36-248217, 36-248223, 36-248230, 36-248235, Exp. 8/13/2023; 36-248996, 36-249236, Exp. 8/16/2023; 36-249321, 36-249322, 36-249323, Exp. 8/17/2023; 36-249516, 36-249517, Exp. 8/18/2023; 36-249737, 36-249741, 36-249742, 36-249743, 36-249744, 36-249745, Exp. 8/21/2023; 36-250073, 36-250075, 36-250076, Exp. 8/22/2023; 36-251191, 36-251192, 36-251193, Exp. 8/24/2023; 36-251611, 36-251612, Exp. 8/28/2023; 36-252326, 36-252328, Exp. 8/31/2023; 36-254328, 36-254330, 36-254334, Exp. 9/4/2023; 36-254948, 36-254949, 36-254950, 36-254951, 36-254952, 36-254954, 36-254955, Exp. 9/6/2023; 36-255633, 36-255635, 36-255636, Exp. 9/7/2023.
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-0965-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 14, 2023
- FDA report date
- Aug 9, 2023
- Quantity
- 499,304 Syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-0965-2023, 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: 36-239063, 36-239064, 36-239065, 36-239066, 36-239067, 36-23906, 736-239068, 36-239069, 36-239204, Exp. 7/10/2023; 36-239196, 36-239197, 36-239198, 36-239199, 36-239200, 36-239201, 36-239202, 36-239203, 36-239205, 36-239206, Exp. 7/11/2023; 36-239483, 36-239487, 36-239488, 36-239489, 36-239490, 36-239639, 36-239640, 36-239641, Exp. 7/12/2023; 36-239788, 36-239789,36-239790, 36-239793, 36-239797, 36-239798, Exp. 7/13/2023; 36-240139, 36-240140, 36-240141, 36-240142, 36-240143, Exp. 7/16/2023; 36-240319, 36-240320, 36-240321 ,36-240322, 36-240812, Exp. 7/17/2023; 36-241074, 36-241075, 36-241076, 36-241077, Exp. 7/18/2023; 36-241136, Exp. 7/19/2023; 36-241357, 36-241358, 36-241359, 36-241372, 36-241373, Exp. 7/20/2023; 36-241715, 36-241718, 36-241719, 36-241720, 36-241721, 36-241723, 36-241850, Exp. 7/21/2023; 36-241918, 36-241919, 36-241920, 36-242184, Exp. 7/23/2023; 36-241993, 36-241994, 36-241995, 36-241997, Exp. 7/24/2023; 36-242402, 36-242403, 36-242404, 36-242405, 36-242406, 36-242913, Exp. 7/25/2023; 36-242630, 36-242631, 36-242632, 36-242633, 36-242634, Exp. 7/26/2023; 36-242799, 36-242800, 36-242801, 36-242802, 36-242803, 36-242806, Exp. 7/27/2023; 36-243537, 36-243538, 36-243539, Exp. 7/30/2023; 36-243820, 36-243822, 36-244311, 36-243819, Exp. 7/31/2023; 36-244877, 36-244878, 36-244879, 36-245572, 36-245574, Exp. 8/1/2023; 36-245805, 36-246140, 36-246141, 36-246142, 36-246143, Exp. 8/2/2023; 36-246292, 36-246293, 36-246294, 36-246295, 36-246296, 36-246297, Exp. 8/3/2023; 36-246696, 36-246697, 36-246700, 36-246702, Exp. 8/6/2023; 36-246780, 36-246781, 36-246782, 36-246784, 36-247058, Exp. 8/7/2023; 36-248214, 36-248217, 36-248223, 36-248230, 36-248235, Exp. 8/13/2023; 36-248996, 36-249236, Exp. 8/16/2023; 36-249321, 36-249322, 36-249323, Exp. 8/17/2023; 36-249516, 36-249517, Exp. 8/18/2023; 36-249737, 36-249741, 36-249742, 36-249743, 36-249744, 36-249745, Exp. 8/21/2023; 36-250073, 36-250075, 36-250076, Exp. 8/22/2023; 36-251191, 36-251192, 36-251193, Exp. 8/24/2023; 36-251611, 36-251612, Exp. 8/28/2023; 36-252326, 36-252328, Exp. 8/31/2023; 36-254328, 36-254330, 36-254334, Exp. 9/4/2023; 36-254948, 36-254949, 36-254950, 36-254951, 36-254952, 36-254954, 36-254955, Exp. 9/6/2023; 36-255633, 36-255635, 36-255636, Exp. 9/7/2023.
- Postal code
- 85043-3909
- Report date
- Aug 9, 2023
- Product type
- Drugs
- Recall number
- D-0965-2023
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Product quantity
- 499,304 Syringes
- 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 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 14, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 1, 2023