Lidocaine Injectable Solution Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Lidocaine 2% HCl Injectable Solution nationwide due to lack of sterility assurance following an FDA inspection. The recall affects 1,516 bags distributed across the United States.
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 of an injectable drug with sterility assurance concerns. Although no illnesses or injuries have been reported, loss of sterility assurance for injectables poses a significant risk of infection, qualifying this as a high-risk product with no yet-reported harm.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Lidocaine 2% HCl Injectable Solution, 500mL bags (NDC 71285-8091-1) nationwide because the company cannot assure the product is sterile. An FDA inspection raised questions about whether these injectable products are actually sterile.
The recalled product was distributed nationwide in the USA. Specific affected lots are: Lot # 37-870983 (Exp 06/10/2023), Lot # 37-879653 (Exp 07/16/2023), Lot # 37-879654 (Exp 07/16/2023), Lot # 37-883186 (Exp 07/29/2023), Lot # 37-888533 (Exp 08/20/2023), and Lot # 37-893416 (Exp 09/09/2023). A total of 1,516 bags were distributed.
Healthcare providers and hospitals in possession of this product should stop using it immediately and return it to the manufacturer.
The recalled product
- Product
- Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8091-1, code 7128580911.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,516
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 (11)
- Lot # 37-870983
- Exp 06/10/2023
- 37-879653
- 37-879654
- Exp 07/16/2023
- 37-883186
- Exp 07/29/2023
- 37-888533
- Exp 08/20/2023
- 37-893416
- Exp 09/09/2023
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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