Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Summary
The FDA issued a Class II for Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle by Aspen Biopharma Labs Pvt., Ltd.. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0264-2025
Action Date
2025-03-19
Status
Ongoing
Category
drug
Product Description
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Lot/Code Info: Lot Numbers: HALAC0010123, exp. date Dec-2026 HALAC0050923, exp. date Aug-2027
Quantity Affected: 150.0 gm
Reason for Recall
CGMP Deviations
Distribution
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-07
Company
Medchal Malkajgiri
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 61 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Aspen Biopharma Labs Pvt., Ltd. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aspen Biopharma Labs Pvt., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aspen Biopharma Labs Pvt., Ltd. have FDA actions?
Aspen Biopharma Labs Pvt., Ltd. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0264-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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