Drug recall D-0554-2026

Class II Ongoing reported Jun 10, 2026

Product

Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.

Reason for recall

Lack of Assurance of Sterility

Lots and codes

Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.

Recall details

Recalling firm
Spectra Medical Devices, Llc, Wilmington, MA
Quantity
210625 ampules
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 12, 2026

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