FDA (Drugs) recall action 79860
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.
Subpotent Drug
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.
Lyne Laboratories is recalling 17,939 units of Fluocinolone Acetonide Topical Oil ear drops because the medication is subpotent.
Lyne Laboratories is recalling 23,453 units of Fluocinolone Acetonide Topical Oil because the product is subpotent. The recall is voluntary and classified as FDA Class II.
Lyne Laboratories is recalling 12,572 units of Fluocinolone Acetonide Topical Oil because the product is subpotent. The recall is voluntary and was initiated by the firm.