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Aidarex Pharmaceuticals LLC

Recalls

Recalls by year

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

Recalls by year
YearRecalls
20141
20163
20172
20184
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FDA Recall Terminated Historical recordClass III

Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30

by Aidarex Pharmaceuticals LLC

Reason
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Published
August 1, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90

by Aidarex Pharmaceuticals LLC

Reason
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Published
August 1, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90

by Aidarex Pharmaceuticals LLC

Reason
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Published
August 1, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00

by Aidarex Pharmaceuticals LLC

Reason
Presence of Foreign Tablets/Capsules
Published
May 23, 2018
Distribution
Product was distributed to Florida

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FDA Recall Terminated Historical recordClass III

ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.

by Aidarex Pharmaceuticals LLC

Reason
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Published
November 1, 2017
Distribution
Product was distributed in Florida

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FDA Recall Terminated Historical recordClass III

Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30

by Aidarex Pharmaceuticals LLC

Reason
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Published
September 20, 2017
Distribution
Distributed to the state of CA and NV.

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FDA Recall Terminated Historical recordClass III

Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01

by Aidarex Pharmaceuticals LLC

Reason
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Published
July 6, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.

by Aidarex Pharmaceuticals LLC

Reason
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Published
June 15, 2016
Distribution
U.S. including: CA, ND, PA, TN

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FDA Recall Terminated Historical recordClass III

CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01

by Aidarex Pharmaceuticals LLC

Reason
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Published
June 15, 2016
Distribution
IN and GA

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FDA Recall Terminated Historical recordClass II

Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India

by Aidarex Pharmaceuticals LLC

Reason
Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
Published
October 29, 2014
Distribution
Nationwide

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Showing 1–10 of 10 results

This page lists recalls that name Aidarex Pharmaceuticals 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.