Class II · Moderate risk
Tirzepatide/Niacinamide 2mL vial
Lack of assurance of sterility.
FOCUS PI Hypromellose 0.7% Formula (Hypromellose Eye Drops 0.7%)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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
Affected NDC
82724-0007-19
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Focus PI Hypromellose Eye Drops 0.7% NDC 82724-0007 |
HYPROMELLOSE 2910 (4000 MPA.S) 7 mg/mL | For Solution Ophthalmic |
Covalent Medical | OTC |
- Recalling firm
- Aurolab Trust
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0874-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
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