Home / Recalls / Mylan Pharmaceuticals Inc. / D-1186-2018

D-1186-2018 Class III Terminated

Recalled by Mylan Pharmaceuticals Inc. — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
September 19, 2018
Initiation Date
August 7, 2018
Termination Date
August 14, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,799 bottles of 100

Product Description

Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01

Reason for Recall

Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.

Distribution Pattern

Distributed Nationwide in the US

Code Information

Batch code # 3093163, expiration date 04/2019

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  • 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)