Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Puralube Petrolatum Ophthalmic Ointment
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
Puralube Petrolatum Ophthalmic Ointment, Net Wt 3.5 gram (1/8 oz), Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-35
Affected NDC
0574-4025-35
Compare with the code on your package — it is the most precise check available.
Category: Eye Drops & Ophthalmic
- Recalling firm
- Altaire Pharmaceuticals, Inc.
- NDC code
- 0574-4025-35
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0473-2020 · 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. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Altaire Pharmaceuticals, Inc.
All 2019 recalls
Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Grandall Oftal-Mycin Ophthalmic Ointment
Lack of Assurance of Sterility
Other sterility / contamination recalls from 2019
All sterility / contamination recalls
Class II · Moderate risk
Trimix Super
Lack of sterility assurance.
Class II · Moderate risk
TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
Trimix Forte 4
Lack of sterility assurance.
Class II · Moderate risk
TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion
Lack of sterility assurance.
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