Mylan Institutional D B A Udl Laboratories recalls

Mylan Institutional D B A Udl Laboratories appears in 22 official U.S. recall notices indexed by RecallRadar, most recently on 2022-05-18.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carto…
  FDA Drug · Class II · 2022-05-18 · Mylan Institutional D B A Udl Laboratories
  Reason: Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
• Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carto…
  FDA Drug · Class II · 2022-05-18 · Mylan Institutional D B A Udl Laboratories
  Reason: Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
• Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 5…
  FDA Drug · Class II · 2019-03-27 · Mylan Institutional D B A Udl Laboratories
  Reason: Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
• Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by:…
  FDA Drug · Class III · 2018-08-29 · Mylan Institutional D B A Udl Laboratories
  Reason: Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
• Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc
  FDA Drug · Class II · 2018-05-30 · Mylan Institutional D B A Udl Laboratories
  Reason: GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
• Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc
  FDA Drug · Class II · 2018-05-30 · Mylan Institutional D B A Udl Laboratories
  Reason: GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
• Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc…
  FDA Drug · Class II · 2017-04-05 · Mylan Institutional D B A Udl Laboratories
  Reason: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
• Mirtazapine Tablets, USP, 45 mg
  FDA Drug · Class II · 2017-03-15 · Mylan Institutional D B A Udl Laboratories
  Reason: Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
• Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceut…
  FDA Drug · Class III · 2016-11-16 · Mylan Institutional D B A Udl Laboratories
  Reason: Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
• Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit d…
  FDA Drug · Class III · 2016-11-16 · Mylan Institutional D B A Udl Laboratories
  Reason: Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
• Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20
  FDA Drug · Class II · 2016-08-31 · Mylan Institutional D B A Udl Laboratories
  Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
• Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-coun…
  FDA Drug · Class II · 2016-08-31 · Mylan Institutional D B A Udl Laboratories
  Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
• Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20
  FDA Drug · Class II · 2016-08-31 · Mylan Institutional D B A Udl Laboratories
  Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
• Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-88…
  FDA Drug · Class III · 2016-02-10 · Mylan Institutional D B A Udl Laboratories
  Reason: Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
• Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only
  FDA Drug · Class III · 2015-11-25 · Mylan Institutional D B A Udl Laboratories
  Reason: Failed Impurities/Degradation Specifications: Out of specification for impurities.
• Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: M…
  FDA Drug · Class III · 2015-05-27 · Mylan Institutional D B A Udl Laboratories
  Reason: Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
• CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmace…
  FDA Drug · Class II · 2015-01-28 · Mylan Institutional D B A Udl Laboratories
  Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
• LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharm…
  FDA Drug · Class II · 2015-01-28 · Mylan Institutional D B A Udl Laboratories
  Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
• Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by:…
  FDA Drug · Class III · 2014-07-23 · Mylan Institutional D B A Udl Laboratories
  Reason: Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
• Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qual…
  FDA Drug · Class III · 2014-03-19 · Mylan Institutional D B A Udl Laboratories
  Reason: Failed Impurity/degradation Specification
• Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Man…
  FDA Drug · Class III · 2013-05-29 · Mylan Institutional D B A Udl Laboratories
  Reason: Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
• Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg
  FDA Drug · Class I · 2013-02-27 · Mylan Institutional D B A Udl Laboratories
  Reason: Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.