Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls
FDA enforcement reports naming Mylan Institutional, Inc. (d.b.a. UDL Laboratories) as the recalling firm.
- Recall reports
- 22
- Class I (serious)
- 1
- Most recent report
- May 18, 2022
- May 18, 2022Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blist…Drug · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.Class II
- May 18, 2022Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blist…Drug · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.Class II
- Mar 27, 2019Alprazolam Tablets, USP, 0Drug · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.Class II
- Aug 29, 2018Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10…Drug · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturerClass III
- May 30, 2018Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured…Drug · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contaminationClass II
- May 30, 2018Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured…Drug · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contaminationClass II
- Apr 5, 2017Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton,…Drug · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.Class II
- Mar 15, 2017Mirtazapine Tablets, USP, 45 mgDrug · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingledClass II
- Nov 16, 2016Clonazepam Tablets, USP, 0Drug · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.Class III
- Nov 16, 2016Clonazepam Tablets, USP, 1Drug · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.Class III
- Amlodipine Besylate Tablets, USP, 2
- Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose…
- Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose b…
- Clonazepam Tablets, USP, 0
- Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister…
- Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100…
- CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card
- LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister card…
- Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10)…
- Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards…
- Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x…
- Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg
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