Phenylephrine injectable drug recalled due to sterility assurance failure
Central Admixture Pharmacy Services Inc is recalling 3,384 phenylephrine syringes due to lack of assurance of sterility. The product was distributed nationwide.
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: FDA Class II recall for an injectable pharmaceutical with sterility assurance failure. No illnesses, injuries, or deaths are reported; the hazard is theoretical. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services Inc is recalling 3,384 10 mL syringes of phenylephrine in 0.9% sodium chloride (40 mcg/mL) due to lack of assurance of sterility. This injectable pharmaceutical product must remain sterile for safe use.
The affected syringes were distributed nationwide. The product is identified by NDC 71286-6007-1 and includes multiple lot numbers with expiration dates in October 2023: lots 17-275231 and 17-275232 expire 10/2/2023; lots 17-275563, 17-275567, 17-275573, and 17-275580 expire 10/8/2023; and lots 17-275767 and 17-275784 expire 10/10/2023.
Healthcare facilities and individuals who possess this product should not use it due to the sterility assurance failure.
The recalled product
- Product
- PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable
- Hazard
- sterility-assurance
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 (11)
- Lot: 17-275231
- 17-275232
- Exp. 10/2/2023
- 17-275563
- 17-275567
- 17-275573
- 17-275580
- Exp. 10/8/2023
- 17-275767
- 17-275784
- Exp. 10/10/2023
Distribution
Distributed nationwide across the United States.
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