Asclemed USA Inc.: Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceutic
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Asclemed USA Inc.
- 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.
- Reason / hazard
- Lack of Assurance of Sterility
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- USA Nationwide
- Recall initiated
- 2026-06-08
- Code info
- 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.
- Product quantity
- N/A
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Torrance
- State
- CA
- Country
- United States
- Event id
- 99204
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