Drug Enforcement D-0512-2024

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

June 5, 2024

Termination Date

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Product Information

Product description
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01
Product quantity
14,180 vials
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
—
Initial firm notification
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Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Imprimis NJOF, LLC
Address
1705 Route 46 Ste 6B

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0512-2024
Event ID
94551
Recall initiation date
May 14, 2024
Center classification date
May 29, 2024
Code info
Lot #: 23APR033, Exp. Date 5/1/24; 23JUN001, Exp. Date 6/5/24
More code info
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