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Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Recalls

All product recalls associated with Mylan Institutional, Inc. (d.b.a. UDL Laboratories).

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Apr 2022

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 22 recalls

Esomeprazole Magnesium Capsules (Mylan) – Impurity Specification (2022)

Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.

Class IIModerate

FDAApr 1, 2022Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Esomeprazole Magnesium Capsules (Mylan) – Impurity Specification Failure (2022)

Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.

Class IIModerate

FDAApr 1, 2022Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Alprazolam Tablets (Mylan) – impurity specification (2019)

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Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.

Class IIModerate

FDAJan 18, 2019Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Diltiazem HCl Capsules (Mylan) – Impurity Specifications (2018)

Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer

Class IIILow

FDAAug 14, 2018Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Loxapine Capsules 50mg (Mylan) – Manufacturing Risk (2018)

GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination

Class IIModerate

FDAMay 1, 2018Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Loxapine Capsules 25mg (Mylan) – Manufacturing Risk (2018)

GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination

Class IIModerate

FDAMay 1, 2018Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Atorvastatin Calcium Tablets 10mg (Mylan) – Microbial Contamination (2017)

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Class IIModerate

FDAMar 21, 2017Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Mirtazapine Tablets (Mylan) – Foreign Tablet Contamination (2017)

Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled

Class IIModerate

FDAJan 27, 2017Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Clonazepam Tablets 1.0mg (Mylan) – Impurity Issue (2016)

Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.

Class IIILow

FDASep 28, 2016Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Clonazepam Tablets 0.5mg (Mylan) – Impurity Issue (2016)

Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.

Class IIILow

FDASep 28, 2016Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Clonazepam (Mylan) – Impurity Specification Failure (2016)

Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.

Class IIILow

FDAJan 28, 2016Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Meclizine Tablets (Mylan) – Impurity Specification (2015)

Failed Impurities/Degradation Specifications: Out of specification for impurities.

Class IIILow

FDANov 2, 2015Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Fexofenadine Tablets (Mylan) – Impurity Specification (2015)

Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing

Class IIILow

FDAMar 26, 2015Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Diltiazem HCl Extended-release Capsules (Mylan) – Impurity Specification Failure (2014)

Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.

Class IIILow

FDAJul 3, 2014Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Carisoprodol Tablets (Mylan) – Impurity Specification Failure (2014)

Failed Impurity/degradation Specification

Class IIILow

FDAJan 28, 2014Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Ciprofloxacin Tablets (Mylan) – CGMP Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

Class IIModerate

FDASep 26, 2013Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Lamotrigine Tablets (Mylan) – CGMP Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

Class IIModerate

FDASep 26, 2013Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Amlodipine Tablets 5mg (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 17, 2013Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Amlodipine Tablets 2.5mg (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 17, 2013Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Amlodipine Tablets 10mg (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 17, 2013Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)