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AuroMedics Pharma LLC

Recalls

Recalls by year

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

Recalls by year
YearRecalls
201813
201915
20203
20211
20224
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FDA Recall Terminated Historical recordClass II

Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe)

by AuroMedics Pharma LLC

Reason
Subpotent Drug: Out of specification for assay
Published
November 2, 2022
Distribution
Nationwide

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FDA Recall Completed Historical recordClass II

Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10.

by AuroMedics Pharma LLC

Reason
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Published
October 26, 2022
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass III

Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10

by AuroMedics Pharma LLC

Reason
Presence of Particulate Matter: Piece of metal found in a vial
Published
October 12, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10

by AuroMedics Pharma LLC

Reason
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Published
February 16, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India NDC 55150-307-01

by AuroMedics Pharma LLC

Reason
Discoloration and failed pH specifications
Published
February 10, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for Use in Newborns, Contains Benzyl Alcohol, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ, 08520, Made in India, NDC 55150-295-20.

by AuroMedics Pharma LLC

Reason
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Published
February 26, 2020
Distribution
Ohio, Louisiana, Mississippi

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FDA Recall Terminated Historical recordClass II

Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20

by AuroMedics Pharma LLC

Reason
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Published
February 19, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.

by AuroMedics Pharma LLC

Reason
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Published
January 22, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99

by AuroMedics Pharma LLC

Reason
Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
Published
December 25, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05

by AuroMedics Pharma LLC

Reason
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Published
December 18, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05

by AuroMedics Pharma LLC

Reason
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Published
December 18, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.

by AuroMedics Pharma LLC

Reason
Discoloration: Product complaints of discoloration after reconstitution of vials.
Published
December 18, 2019
Distribution
Nationwide

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This page lists recalls that name AuroMedics Pharma 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.