← FDA ENFORCEMENT
D-0264-2025Class II

Aspen Biopharma Labs Pvt., Ltd.

Recalling firm
Aspen Biopharma Labs Pvt., Ltd.
Product type
Drug
Status
Ongoing
Report date
2025-03-19
Distribution
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
Product quantity
150.0 gm
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations

Product description

Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle

Code / lot info

Lot Numbers: HALAC0010123, exp. date Dec-2026 HALAC0050923, exp. date Aug-2027

Other recalls SPEQ maps to Risk Management & CAPA
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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.