Drug Enforcement D-0543-2024

Failed Impurities/Degradation Specifications.

Status

Ongoing

Classification

Class III

Report Date

June 12, 2024

Termination Date

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Product Information

Product description
Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8
Product quantity
13,440 units
Reason for recall
Failed Impurities/Degradation Specifications.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Zydus Pharmaceuticals (USA) Inc
Address
73 Route 31 N, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0543-2024
Event ID
94649
Recall initiation date
May 16, 2024
Center classification date
June 6, 2024
Code info
Lot #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25
More code info
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