Aurolab Trust — Class II: FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for:
Aurolab Trust has initiated a Class II recall for FOCUS PI Hypromellose 0.7% Formula (10 mL vials) due to a lack of assurance of sterility. The recall, which is currently ongoing, affects product manufactured for Covalent Management, Inc. under NDC 82724-007-19.
This recall affects Aurolab Trust, Covalent Management, Inc., and entities involved in the distribution or clinical use of this specific ophthalmic hypromellose formula.
A Class II recall for lack of sterility assurance in an ophthalmic product suggests potential deficiencies in aseptic processing or environmental monitoring at the manufacturing site. While the source does not detail specific contamination, regulatory professionals should recognize this as a significant compliance failure that often necessitates a thorough review of sterilization validation and media fill records. The involvement of an international firm (India) and a U.S. distributor (Virginia) highlights the importance of robust importer oversight of contract manufacturing organizations.
QA and Supply Chain teams should verify if this NDC (82724-007-19) is in inventory and follow standard quarantine procedures. Regulatory teams should assess foreign supplier oversight protocols, particularly regarding sterility validation documentation for ophthalmic products.
Class II. Reason: Lack of Assurance of Sterility. Product: FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109. NDC: 82724-007-19. Firm: Aurolab Trust (Madurai India). Status: Ongoing.
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