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Recall Observatory FDA recall evidence

Drug product

Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.

D-0658-2026

June 08, 2026

Class II

Product summary

Firm
Asclemed USA Inc.
Event
Event 99204
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0658-2026

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: AE3102, 121924X2, 022525X4, 033125X1, 030426X2, 033125X2, 041725X3, 061225X1, 072225X3, 080525X6, 080525X7, 080525X8, 091225X1, 100225X2, 100625X1, 122225X4, 010626X3, 041326X4, Exp 11/30/2026; AE5052, 041426X2, 041726X1, 051826X2, Exp 04/30/2028.

Distribution pattern: USA Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility