Injectable Drug Recalled for Unverified Sterility After FDA Inspection
Central Admixture Pharmacy Services is recalling 1673 bags of HyperLyte CR Injection due to lack of sterility assurance. An FDA inspection raised questions about whether the product met sterility standards.
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 an FDA Class II recall for an injectable product with questionable sterility assurance. However, no illnesses or injuries have been reported, and the hazard is theoretical (lack of assurance rather than confirmed contamination). Per the rubric, this scores as High (3) since it represents risk of harm where injury has not yet been reported.
Plain-English summary
HyperLyte CR Injection is being recalled due to lack of assurance of sterility. An FDA inspection raised questions about whether the product met sterility requirements for injectable medications. The product is a 250 mL injection supplied by Central Admixture Pharmacy Services, Inc., located in Allentown, Pennsylvania.
The recall affects 1673 bags with multiple lot numbers and varying expiration dates from May 2023 through June 2023. The affected product has been distributed nationwide in the United States.
The recalled product
- Product
- HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-2, code 7128580942.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable
- Affected units
- 1,673
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 (16)
- Lot # 37-885553
- 37-885554
- Exp 05/09/2023
- 37-887923
- 37-887924
- Exp 05/18/2023
- 37-890778
- 37-890779
- Exp 05/30/2023
- 37-892847
- Exp 06/07/2023
- 37-895049
- Exp 06/15/2023
- 37-898480
- 37-898481
- Exp 06/29/2023
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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