Home / Recalls / Mylan Pharmaceuticals Inc. / D-0492-2017

D-0492-2017 Class II Terminated

Recalled by Mylan Pharmaceuticals Inc. — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
March 15, 2017
Initiation Date
January 19, 2017
Termination Date
July 12, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
37,445 bottles

Product Description

Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV

Reason for Recall

Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle

Distribution Pattern

Nationwide

Code Information

a) 3078937 and 3078938 (NDC 0378-3545-93), exp August 2019 b) 3078937 (NDC 0378-3545-01), exp August 2019 c) 3078936 (0378-3545-05), exp August 2019

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  • D-0452-2022 Class II — Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topica (January 21, 2022)
  • D-0462-2022 Class I — Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen ( (January 5, 2022)
  • D-0049-2021 Class III — Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packag (October 2, 2020)
  • D-1057-2020 Class III — Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals I (March 23, 2020)