Injectable Lidocaine Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling lidocaine 2% injectables due to inability to assure sterility. Approximately 1,992 syringes distributed nationwide are affected.
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 of a sterile injectable medication where the manufacturer cannot assure sterility. While no illnesses or injuries have been reported, this represents a risk-of-harm product where sterile manufacturing integrity is compromised.
Plain-English summary
Central Admixture Pharmacy Services Inc is recalling lidocaine 2% (100 mg/5 mL) injectable syringes due to a lack of assurance of sterility. The recall affects approximately 1,992 syringes distributed nationwide.
The recalled product is lidocaine 2%, 20 mg/mL supplied in 5 mL syringes, manufactured by Central Admixture Pharmacy Services Inc (NDC 71286-6006-1). The affected lots are 17-275788 (expiring 10/10/2023), 17-275872 (expiring 10/11/2023), 17-275922 (expiring 10/12/2023), and 17-275972 and 17-275973 (both expiring 10/15/2023).
Sterile injectable medications must maintain sterility to prevent harm. The manufacturer was unable to provide assurance that these lots met sterility requirements.
Persons who have received or are using this product should discontinue use and contact the manufacturer or the FDA for guidance on return or disposal of unused product.
The recalled product
- Product
- lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Hazard
- contamination-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 (9)
- Lot: 17-275788
- Exp. 10/10/2023
- 17-275872
- Exp. 10/11/2023
- 17-275922
- Exp. 10/12/2023
- 17-275972
- 17-275973
- Exp. 10/15/2023.
Distribution
Distributed nationwide across the United States.
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