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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

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

by AuroMedics Pharma LLC

Reason
Discoloration; Hazy solution found in one vial instead of a clear solution.
Published
December 11, 2019
Distribution
Product was distributed to major wholesa…

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FDA Recall Terminated Historical recordClass II

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 08520, NDC 55150-165-05.

by AuroMedics Pharma LLC

Reason
Presence of Foreign Substance: Foreign material found inside the vial.
Published
December 4, 2019
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

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

by AuroMedics Pharma LLC

Reason
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Published
December 4, 2019
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

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

by AuroMedics Pharma LLC

Reason
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Published
December 4, 2019
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

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

by AuroMedics Pharma LLC

Reason
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Published
December 4, 2019
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

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

by AuroMedics Pharma LLC

Reason
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Published
December 4, 2019
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

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

by AuroMedics Pharma LLC

Reason
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Published
December 4, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

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

by AuroMedics Pharma LLC

Reason
Crystallization: Presence of visible particulate matter.
Published
December 4, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

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

by AuroMedics Pharma LLC

Reason
Crystallization: Presence of visible particulate matter.
Published
December 4, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

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

by AuroMedics Pharma LLC

Reason
Crystallization: Presence of visible particulate matter.
Published
December 4, 2019
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass III

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

by AuroMedics Pharma LLC

Reason
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
Published
November 6, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

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

by AuroMedics Pharma LLC

Reason
Presence of Particulate Matter: identified as glass and silicone material
Published
July 18, 2018
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.