Urgent Field Safety Notice For Hypromellose Ophtalmic Solution Usp 2.0 % (hpmc) By Appasamy Ocular Devices Private Limited

Recall Summary Appasamy Ocular Devices Private Limited is recalling Hypromellose Ophthalmic Solution USP 2.0% (HPMC), an eye drop product, in Germany and the EU due to unspecified safety concerns identified during a risk assessment. This is a Class I recall, the most serious classification. The recall affects all distributed units of this eye drop solution in those regions.

Recalling firm
Urgent Field Safety Notice for HYPROMELLOSE OPHTALMIC SOLUTION USP 2.0 % (HPMC) by APPASAMY OCULAR DEVICES PRIVATE LIMIT
Product
s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for HYPROMELLOSE OPHTALMIC SOLUTION USP 2
Reason
assessment Field corrective actions Urgent Field Safety Notice for HYPROMELLOSE OPHTALMIC SOLUTION USP 2
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-06-09
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/5eca13ed-0662-4795-9299-b06215969966