Drug Enforcement D-0261-2025

CGMP violations

Status

Ongoing

Classification

Class II

Report Date

March 19, 2025

Termination Date

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Product Information

Product description
Alprostadil Container Description: Amber color bottle
Product quantity
3.0 gm
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-0261-2025
Event ID
96209
Recall initiation date
February 7, 2025
Center classification date
March 9, 2025
Code info
Lot Numbers: HAALC0020922 exp. date AUG-2025
More code info
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