Phenylephrine Injectable Syringes Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 4,100 syringes of phenylephrine injectable solution due to inadequate validation of sterilization cycles. The lack of documented sterilization assurance creates potential for microbial contamination.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of injectable medication where the hazard is lack of sterility assurance due to unvalidated sanitization processes. No illnesses or injuries have been reported, and the risk is theoretical rather than confirmed. Per the rubric, theoretical risks without reported harm score as High.
Plain-English summary
Central Admixture Pharmacy Services, Inc. has recalled 4,100 syringes of phenylephrine 1,000 mcg/10 mL (100 mcg/mL) injectable solution. The product was distributed nationwide across the United States.
The manufacturer lacks validation data demonstrating that sterilization cycles used in production adequately eliminate microorganisms. Without documented evidence that sanitization processes meet required standards, the company cannot assure the product meets FDA sterility requirements for injectable medications.
Phenylephrine is a vasoconstrictor medication administered intravenously or intramuscularly in clinical settings. Without verified sterilization, the product poses a potential risk of microbial contamination and associated infection.
Affected lot numbers are 36-262311, 36-262312, 36-262313, and 36-262314 (expiring 10/5/2023) and 36-262737, 36-262738, 36-262739, 36-262740, 36-262741, and 36-262742 (expiring 10/11/2023). Healthcare facilities and distributors should identify and quarantine affected units by lot number and not administer them to patients.
The recalled product
- 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
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable Medication
- Hazard
- lack-of-sterility
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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.
Distribution
Distributed nationwide across the United States.
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