Class II · Moderate risk
Oasis Tears PF
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
HPMC Visoelastic Topical
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741
- Recalling firm
- Oasis Medical, Inc.
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0523-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Oasis Medical, Inc.
All 2015 recalls
Class III · Low risk
HPMC Visoelastic
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk
HPMC Visoelastic
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk
ImproVue Ophthalmic Lubricant Drops
Falied pH specification
Other failed specification recalls from 2015
All failed specification recalls
Class III · Low risk
Paricalcitol Capsules
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Class III · Low risk
Paricalcitol Capsules
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Class III · Low risk
Paricalcitol Capsules
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Class III · Low risk
HPMC Visoelastic
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
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