Home / Recalls / Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / D-0861-2022

D-0861-2022 Class II Terminated

Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) — Rockford, IL

Recall Details

Product Type
Drugs
Report Date
May 18, 2022
Initiation Date
April 1, 2022
Termination Date
June 9, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
885 cartons

Product Description

Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16

Reason for Recall

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

Distribution Pattern

Nationwide within USA

Code Information

Lot #: 3110437, 3111409, 3110785, Exp. Date 7/31/2022; 3112173, Exp. Date 11/30/2022

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

  • D-0860-2022 Class II — Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dos (April 1, 2022)
  • D-1013-2019 Class II — Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: M (January 18, 2019)
  • D-1112-2018 Class III — Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister card (August 14, 2018)
  • D-0823-2018 Class II — Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manuf (May 1, 2018)
  • D-0822-2018 Class II — Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manuf (May 1, 2018)
  • D-0622-2017 Class II — Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per (March 21, 2017)
  • D-0493-2017 Class II — Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured (January 27, 2017)
  • D-0135-2017 Class III — Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x (September 28, 2016)
  • D-0136-2017 Class III — Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x (September 28, 2016)
  • D-0650-2016 Class III — Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Myla (January 28, 2016)