Eugia US LLC recall Methylprednisolone acetate injections for failed dissolution

Eugia US LLC is recalling three lots of Methylprednisolone acetate Injectable Suspension (80mg/mL, 5mL Multiple-Dose Vial) in US. The Class II recall is initiated due to failed Dissolution Specifications. Methylprednisolone acetate injectable suspension is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection.

The product is manufactured by Eugia Pharma Specialities Limited in India and distributed by Eugia US LLC. Both Eugia US LLC (December 2023) and Eugia Pharma Specialities Limited (February 2024) were issued USFDA 483 citing lapses observed during USFDA inspections recently.

USFDA Enforcement report