Drug Enforcement D-0262-2025

CGMP violations

Status

Ongoing

Classification

Class II

Report Date

March 19, 2025

Termination Date

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Product Information

Product description
Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
Product quantity
120.0 kg
Reason for recall
CGMP violations
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)

Location & Firm

Recalling firm
Aspen Biopharma Labs Pvt., Ltd.
Address
Plot No 10, Biotech Park Phase-II, Lalgadi Malakpet Village,Turkapally, Shameerpet Mandal

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0262-2025
Event ID
96209
Recall initiation date
February 7, 2025
Center classification date
March 9, 2025
Code info
Lot Numbers: HAFSC0040923, exp. date Aug-2027 HAFSC0050923, exp. date Aug-2027
More code info
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