Drug Enforcement D-0260-2025

CGMP violations

Status

Ongoing

Classification

Class II

Report Date

March 19, 2025

Termination Date

—

Product Information

Product description
Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
Product quantity
400.0 gm
Reason for recall
CGMP violations
Recall initiation reason
—
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
—

Codes & Dates

Recall number
D-0260-2025
Event ID
96209
Recall initiation date
February 7, 2025
Center classification date
March 9, 2025
Code info
Lot Numbers: HABTC0020123, exp. date Dec-2026 HABTC0050623, exp. date May-2027 HABTC0091023, exp. date Sep-2028
More code info
—