← FDA ENFORCEMENT
D-0543-2024Class III

Zydus Pharmaceuticals (USA) Inc

Recalling firm
Zydus Pharmaceuticals (USA) Inc
Product type
Drug
Status
Ongoing
Report date
2024-06-12
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
13,440 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Impurities/Degradation Specifications.

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

Code / lot info

Lot #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.