Phenylephrine Syringes Recalled Nationwide for Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 3,081 phenylephrine injectable syringes nationwide due to lack of assurance of sterility. Affected lots expire between October 3-18, 2023.
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 a sterility assurance failure on an injectable medication. This qualifies as 'High' per the rubric as a risk-of-harm product where injury has not yet been reported, and no illnesses, serious injuries, or deaths are documented.
Plain-English summary
Central Admixture Pharmacy Services Inc is recalling 3,081 syringes of PHENYLephrine in 0.9% sodium chloride (80 mcg/mL, 10 mL syringes) distributed nationwide in the United States. The product is supplied by CAPS, Inc., located at 7935 Dunbrook Road, Suite C, San Diego, CA 92126.
The recall is due to lack of assurance of sterility. The affected lots are: 17-275323, 17-275345 (expiration 10/3/2023); 17-275642, 17-275643, 17-275671 (expiration 10/8/2023); 17-275675, 17-275677 (expiration 10/9/2023); and 17-276188 (expiration 10/18/2023).
This product is an injectable medication distributed nationwide. Healthcare providers and patients who have received or possess this product should verify the lot numbers and expiration dates against the recall list.
The recalled product
- Product
- PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable Medication
- Hazard
- sterility-failure
- infection-risk
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: 17-275323
- 17-275345
- Exp. 10/3/2023
- 17-275642
- 17-275643
- 17-275671
- Exp. 10/8/2023
- 17-275675
- 17-275677
- Exp. 10/9/2023
- 17-276188
- Exp. 10/18/2023
Distribution
Distributed nationwide across the United States.
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