Recalls / Class II
Class IID-1124-2023
Product
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
- Affected lot / code info
- Lot# 36-262312, 36-262314, 36-262311, 36-262313, Exp 10/5/2023; 36-262739, 36-262742, 36-262741, 36-262740, 36-262738, 36-262737, Exp 10/11/2023. ;
Why it was recalled
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recalling firm
- Firm
- Central Admixture Pharmacy Services, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2200 S 43rd Ave, N/A, Phoenix, Arizona 85043-3909
Distribution
- Quantity
- 4100 syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-08-17
- FDA classified
- 2023-08-28
- Posted by FDA
- 2023-09-06
- Terminated
- 2025-03-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1124-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.