Phenylephrine Injection Syringes Recalled Due to Sterility Validation Failure
Central Admixture Pharmacy Services Inc. is recalling 16,971 syringes of phenylephrine injection due to lack of validation data for sterilization processes. 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: This is an FDA Class II recall of an injectable drug with unvalidated sterilization procedures. While no illnesses or injuries have been reported, the lack of validation data for sanitization cycles represents a genuine risk-of-harm for an injectable medication. The hazard is real but not yet manifested in reported harm, warranting a High severity classification.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling 16,971 syringes of phenylephrine in 0.9% sodium chloride solution (40 mcg/mL, NDC 71286-6007-1). The product was distributed nationwide in the United States.
The recall is due to lack of validation data for sanitization cycles used to sterilize the product. Without validated sterilization procedures, there is no assurance that the product meets the sterility standards required for injectable medications.
Multiple lots are affected with expiration dates from July through September 2023, including lot numbers 17-270510, 17-270512, 17-270665, 17-270699, 17-270812, 17-271062, and others. Healthcare providers should immediately cease use of any affected lots and notify patients who may have received these products.
Patients and healthcare professionals with questions should contact the manufacturer or consult the FDA website for additional information on this recall.
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 Pharmaceutical
- Affected units
- 16,971
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 (20)
- Lot: 17-270510
- 17-270512
- Exp. 7/16/2023
- 17-270665
- 17-270699
- Exp. 7/18/2023
- 17-270812
- Exp. 7/19/2023
- 17-271062
- 17-271063
- 17-271064
- 17-271065
- Exp. 7/24/2023
- 17-271350
- 17-271357
- 17-271421
- 17-271422
- Exp. 7/30/2023
- 17-271836
- 17-271848
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 recalled by Central Admixture Pharmacy Services Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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