Spectra lidocaine ampules recalled over lack of sterility assurance
Lidocaine HCl Injection USP in 5 mL single-dose ampules distributed by Spectra Medical Devices is being recalled for lack of assurance of sterility. 210,625 ampules 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: FDA Class II recall of a sterile injectable where sterility cannot be assured, a risk of harm with no injuries reported in the source.
Plain-English summary
Lidocaine HCl Injection USP, supplied as 25 x 5 mL single-dose ampules, distributed by Spectra Medical Devices, LLC of Wilmington and made in South Korea, NDC 65282-1605-1, is being recalled. The action covers 210,625 ampules.
The stated reason is lack of assurance of sterility. Sterility is a defining requirement of an injectable product because it is introduced directly into tissue. The FDA classified the action as Class II.
Affected lots are AE4013 (expiry 1/31/2027), AE5032 and AE5039 (expiry 3/31/2028) and AE5104 (expiry 8/31/2028). Distribution was USA nationwide.
This is a prescription product supplied to healthcare facilities. Facilities should check stock against the lot numbers above, quarantine affected ampules and follow the instructions issued by the distributor.
The recalled product
- Product
- LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE ANHYDROUS)
- Brand
- LIDOCAINE HYDROCHLORIDE
- Manufacturer
- Spectra Medical Devices, Llc
- Category
- Drug — Injectable anesthetic
- Hazard
- sterility-assurance
- injectable
- class-ii
- prescription-drug
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 (6)
- Lot#: AE4013
- Exp 1/31/2027
- AE5032 & AE5039
- Exp 3/31/2028
- AE5104
- Exp 8/31/2028.
UPCs (1)
- 0365282160515
Distribution
Distributed nationwide across the United States.
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