Phenylephrine Injectable Solution Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 6,407 bags of phenylephrine injectable solution nationwide because FDA inspection questioned the sterility assurance of the product.
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 with no reported illnesses or injuries. The hazard—lack of sterility assurance in an injectable product—represents a risk-of-harm scenario where injury has not yet been reported, placing it in the High (3) severity category.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling phenylephrine added to 0.9% sodium chloride injection (10 mg/250 mL, 40 mcg/mL) supplied in 250 mL bags. Approximately 6,407 bags have been distributed nationwide.
An FDA inspection questioned whether the product maintains its required sterility. Because these injections must be sterile for safe use, the lack of assured sterility necessitates the recall.
The affected lots include 37-884272, 37-887513, 37-888083, 37-889123, 37-889423, 37-891563, 37-892577, 37-892582, 37-893248, 37-893257, 37-894436, 37-895805, and 37-898324, with expiration dates between May 3, 2023 and June 28, 2023.
The recalled product
- Product
- PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6058-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable Solution
- Hazard
- lack-of-sterility
- 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 (20)
- Lot # 37-884272
- Exp 05/03/2023
- 37-887513
- Exp 05/16/2023
- 37-888083
- Exp 05/18/2023
- 37-889123
- 37-889423
- Exp 05/23/2023
- 37-891563
- Exp 06/01/2023
- 37-892577
- 37-892582
- Exp 06/06/2023
- 37-893248
- 37-893257
- Exp 06/08/2023
- 37-894436
- Exp 06/13/2023
- 37-895805
Distribution
Distributed nationwide across the United States.
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