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Imprimis NJOF, LLC

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20211
20233
202410
20254
20263
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FDA Recall Ongoing Historical recordClass II

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

by Imprimis NJOF, LLC

Reason
Lack of Assurance of Sterility
Published
June 5, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

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

by Imprimis NJOF, LLC

Reason
Lack of Assurance of Sterility
Published
June 5, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

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

by Imprimis NJOF, LLC

Reason
Lack of Assurance of Sterility
Published
June 5, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass III

Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01

by Imprimis NJOF, LLC

Reason
Out of specification for assay
Published
May 8, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08

by Imprimis NJOF, LLC

Reason
Subpotent Drug
Published
May 8, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05

by Imprimis NJOF, LLC

Reason
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Published
October 25, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or (800)-FDA-1088 Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852 (844) 446-6979

by Imprimis NJOF, LLC

Reason
Subpotent: Failing Test Results for Epinephrine
Published
October 11, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.

by Imprimis NJOF, LLC

Reason
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Published
August 30, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979

by Imprimis NJOF, LLC

Reason
Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Published
January 6, 2021
Distribution
Nationwide

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This page lists recalls that name Imprimis NJOF, LLC as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.