East Windsor, NJ, United States
AuroMedics Pharma LLC recalls
23 recalls recorded since 2018, most recently on 30 September 2022. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls23
Ongoing (FDA)3
Terminated or completed20
Class I (FDA)8
Terminated Class II Drugs
- Recall started
- 30 September 2022
- Terminated
- 18 September 2024
- Reason
- Subpotent Drug: Out of specification for assay
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0020-2023
- 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
Ongoing Class III Drugs
- Recall started
- 26 September 2022
- Reason
- Presence of Particulate Matter: Piece of metal found in a vial
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1551-2022
- 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
Completed Class II Drugs
- Recall started
- 26 September 2022
- Reason
- Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0013-2023
- 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.
Terminated Class I Drugs
- Recall started
- 26 January 2022
- Terminated
- 20 August 2024
- Reason
- Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0556-2022
- 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
Terminated Class II Drugs
- Recall started
- 30 December 2020
- Terminated
- 19 September 2023
- Reason
- Discoloration and failed pH specifications
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0248-2021
- 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 55150-3
Terminated Class II Drugs
- Recall started
- 7 February 2020
- Terminated
- 17 November 2022
- Reason
- Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0852-2020
- 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
Terminated Class III Drugs
- Recall started
- 7 February 2020
- Terminated
- 8 March 2023
- Reason
- Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
- Distribution
- Ohio, Louisiana, Mississippi
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0853-2020
- 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,
Terminated Class III Drugs
- Recall started
- 2 December 2019
- Terminated
- 22 November 2022
- Reason
- Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
- Distribution
- Nationwide in the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0789-2020
- 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.
Terminated Class II Drugs
- Recall started
- 25 November 2019
- Terminated
- 4 March 2021
- Reason
- Discoloration: Product complaints of discoloration after reconstitution of vials.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0574-2020
- 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.
Terminated Class I Drugs
- Recall started
- 20 November 2019
- Terminated
- 21 February 2024
- 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.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0636-2020, D-0637-2020
- Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05
- Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05
Terminated Class II Drugs
- Recall started
- 19 November 2019
- Terminated
- 4 April 2023
- Reason
- Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0653-2020
- Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99
Terminated Class II Drugs
- Recall started
- 12 November 2019
- Terminated
- 21 January 2021
- Reason
- Discoloration; Hazy solution found in one vial instead of a clear solution.
- Distribution
- Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0609-2020
- Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ
Terminated Class III Drugs
- Recall started
- 11 November 2019
- Terminated
- 1 April 2021
- Reason
- Crystallization: Presence of visible particulate matter.
- Distribution
- Distributed Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0520-2020, D-0521-2020, D-0522-2020
- Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-180-03
- Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09
- Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18
Terminated Class II Drugs
- Recall started
- 11 November 2019
- Terminated
- 17 November 2020
- Reason
- Presence of Foreign Substance: Foreign material found inside the vial.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0573-2020
- Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ
Ongoing Class II Drugs
- Recall started
- 6 November 2019
- Reason
- CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
- Distribution
- nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0529-2020, D-0528-2020, D-0527-2020, D-0530-2020, D-0526-2020
- Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74
- Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30
- Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60
- Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05
- DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
Ongoing Class III Drugs
- Recall started
- 23 September 2019
- Reason
- CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0166-2020
- Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
Terminated Class I Drugs
- Recall started
- 2 July 2018
- Terminated
- 1 October 2024
- Reason
- Presence of Particulate Matter: identified as glass and silicone material
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1030-2018
- Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Road Dayton NJ 08810, Made in India. NDC 55150-120-30
Terminated Class I Drugs
- Recall started
- 1 May 2018
- Terminated
- 6 November 2024
- Reason
- Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0866-2018
- Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20.
Terminated Class I Drugs
- Recall started
- 1 May 2018
- Terminated
- 21 June 2023
- Reason
- Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0926-2018
- Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ 05610. NDC 55150-120-30
Terminated Class II Drugs
- Recall started
- 27 March 2018
- Terminated
- 18 February 2022
- Reason
- Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0709-2018, D-0707-2018, D-0705-2018, D-0704-2018, D-0708-2018, D-0703-2018, D-0706-2018
- Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured f
- Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47.
- Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-246-47.
- Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured fo
- Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured f
- Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-
- Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-247-47.
Terminated Class I Drugs
- Recall started
- 12 January 2018
- Terminated
- 1 April 2020
- Reason
- Presence of Particulate Matter; contains visible particulate matter identified as mold.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0574-2018
- Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma
Terminated Class I Drugs
- Recall started
- 20 December 2017
- Terminated
- 24 June 2019
- Reason
- Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
- Distribution
- Product was distributed throughout United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0337-2018
- Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51
Terminated Class I Drugs
- Recall started
- 4 December 2017
- Terminated
- 17 March 2020
- Reason
- Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
- Distribution
- Product was distributed nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0340-2018
- Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.