PlainRecordsEpinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free… and 4 more products
- Reason
- Lack of Assurance of Sterility
- Status
- Ongoing
- Distribution
- Nationwide within the United States
- Enforcement report date
- June 5, 2024
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Imprimis NJOF, LLC
- Reason
- Lack of Assurance of Sterility
- Distribution pattern
- Nationwide within the United States
What the record says about this drug
A simplified drawing of a vial, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“Lack of Assurance of Sterility”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, FDA enforcement report, 2024-06-05. The caption is the record's own words.
A generic vial, not the product. The mark follows the record's own words (a question mark, where used, stands for a lack of assurance the record names, not for anything found).
If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.
5 products in this recall
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular…
- Product
- 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
- Quantity
- 14,180 vials
- Codes and lots
- Lot #: 23APR033, Exp. Date 5/1/24; 23JUN001, Exp. Date 6/5/24
- Recall started
- May 14, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall number
- D-0512-2024
Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free…
- Product
- Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-512-01
- Quantity
- 39,700 vials
- Codes and lots
- Lot #: 23MAY016, Exp. Date 5/8/24; 23JUL016, Exp. Date 7/10/24; 23AUG034, Exp. Date 8/16/24; 23DEC014, Exp. Date 12/10/24
- Recall started
- May 14, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall number
- D-0513-2024
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL…
- Product
- Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01
- Quantity
- 38,060 vials
- Codes and lots
- Lot #: 23MAY008, Exp. Date 5/1/24; 23OCT011, Exp. Date 10/26/24; 23NOV035, Exp. Date 12/6/24; 24JAN024, Exp. Date 1/14/25
- Recall started
- May 14, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall number
- D-0514-2024
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection…
- Product
- Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08
- Quantity
- 18,980 vials
- Codes and lots
- Lot #: 23OCT013, Exp. Date 10/10/2024
- Recall started
- May 14, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall number
- D-0515-2024
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection…
- Product
- Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08
- Quantity
- 165,920 vials
- Codes and lots
- Lot #: 23JUN003, Exp. Date 5/29/2024; 23JUL035, Exp. Date 7/24/2024; 23AUG033, Exp. Date 8/14/2024; 23AUG043, Exp. Date 8/21/2024; 23SEP001, Exp. Date 9/26/2024; 23OCT002, Exp. Date 10/4/2024; 23OCT031, Exp. Date 10/31/2024; 23NOV011, Exp. Date 11/28/2024; 24FEB027, Exp. Date 2/15/2025
- Recall started
- May 14, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall number
- D-0516-2024
This recall among the others
- FDA's enforcement report came 22 days after the firm started the recall. For half of the 311 FDA drug recall events reported in 2024 with a start date, it took 27 days or fewer (by year).
- Imprimis NJOF: 5 other recalls or notices on this site in the three years before this one (from June 6, 2021).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? Medicine recall: what to do · How to read this record
Source: FDA · Drug enforcement reports, recall numbers D-0512-2024, D-0513-2024, D-0514-2024, D-0515-2024, D-0516-2024. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record D-0512-2024, June 5, 2024. "Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free… and 4 more products." PlainRecords, https://plainrecords.com/recall/drug/d-0512-2024/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections