FDA Recalls Phenylephrine Injectable Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 1,735 bags of phenylephrine injectable nationwide after FDA inspection raised concerns about product sterility assurance. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 of an injectable medication due to questioned sterility assurance. No reported illnesses or injuries and the hazard is theoretical rather than confirmed contamination, fitting the High severity category for risk-of-harm products without reported injury.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 1,735 bags of a phenylephrine injectable solution (phenylephrine 50 mg in 0.9% sodium chloride, 200 mcg/mL concentration in 250 mL bags) distributed nationwide.
The recall was initiated after an FDA inspection raised questions about the sterility assurance of these products, which are intended for intravenous use. Affected lot numbers are 37-887056, 37-887057, and 37-887059 (expiring May 15, 2023); 37-893807 (expiring June 12, 2023); and 37-896880 (expiring June 22, 2023).
No illnesses or injuries have been reported. Patients or healthcare providers with supplies from the affected lots should consult with their healthcare provider regarding next steps.
The recalled product
- Product
- phenylephrine 50 mg added to 0.9% sodium chloride 250 mL*, 200 mcg/mL*, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7039-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Intravenous Injectable
- Affected units
- 1,735
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 (8)
- Lot # 37-887056
- 37-887057
- 37-887059
- Exp 05/15/2023
- 37-893807
- Exp 06/12/2023
- 37-896880
- Exp 06/22/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 108 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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