Drug Enforcement D-0601-2024

Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.

Status

Ongoing

Classification

Class II

Report Date

July 24, 2024

Termination Date

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Product Information

Product description
Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02.
Product quantity
116,144 bottles
Reason for recall
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA and Puerto Rico

Location & Firm

Recalling firm
Teva Pharmaceuticals USA, Inc
Address
400 Interpace Pkwy Bldg A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0601-2024
Event ID
94900
Recall initiation date
June 28, 2024
Center classification date
July 16, 2024
Code info
Lot #s: CNSDH, Exp. 6/30/2024; CNWVM, CNWWH, Exp. 07/31/2024; CNXKW, CNXKY, CNXMB, CNXMH, Exp. 09/30/2024; CPBTP, CPBTV, Exp. 11/30/2024.
More code info
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