FDA Recalls HyperLyte CR Injection for Lack of Sterility Assurance
The FDA recalled HyperLyte CR Injection because the manufacturer could not assure the product met sterility requirements. The recall affects 554 bags distributed nationwide.
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: This is a sterile pharmaceutical injection where the FDA determined sterility could not be assured. Non-sterile injections present significant risk of serious infection. No illnesses or injuries are documented in the source. Per the rubric, theoretical risk-of-harm products without reported injury warrant a High severity score.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling HyperLyte CR Injection, 500 mL bags, after an FDA inspection determined the manufacturer could not assure the sterility of the product. The product is intended to be sterile. Lot numbers 37-874236 (expiration 06/20/2023) and 37-878694 (expiration 07/10/2023) are affected.
The recall covers 554 bags distributed nationwide in the United States. Healthcare providers and patients should discontinue use of the affected lots. Anyone with concerns about treatments received with this product should consult with their healthcare provider or pharmacist.
The recalled product
- Product
- HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Pharmaceutical Injection
- Affected units
- 554
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 (4)
- Lot # 37-874236
- Exp 06/20/2023
- 37-878694
- Exp 07/10/2023
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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