FDA (Drugs) recall action 72517
The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Oasis Medical, Inc. is recalling HPMC Visoelastic Topical products because the pH may not meet specifications at expiry.
Oasis Medical is recalling HPMC Visoelastic syringes because the pH may not meet specifications at expiry. The recall covers 14,852 units distributed nationwide and internationally.
Oasis Medical, Inc. is recalling HPMC Visoelastic syringes because the pH of the affected lots may not meet specifications at expiry.