Home / Recalls / Mylan Pharmaceuticals Inc. / D-1031-2020

D-1031-2020 Class II Terminated

Recalled by Mylan Pharmaceuticals Inc. — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
March 25, 2020
Initiation Date
March 9, 2020
Termination Date
May 26, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
300 100-count bottles

Product Description

Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01

Reason for Recall

Presence of particulate matter. presence of metal particles.

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lot # 3095754, exp. date 02/2021

Other recalls by Mylan Pharmaceuticals Inc.

  • D-0399-2026 Class II — Isotretinoin Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, R (February 24, 2026)
  • D-0280-2025 Class II — Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan (February 25, 2025)
  • D-1292-2022 Class I — Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL p (July 5, 2022)
  • D-0845-2022 Class I — Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packag (April 12, 2022)
  • D-0774-2022 Class II — Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufact (April 7, 2022)
  • D-0748-2022 Class II — Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufacture (April 1, 2022)
  • 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)