FDA (Drugs) recall action 70807
The FDA (Drugs) publishes a recall like this one as 10 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 10 pages.
Lack of assurance of sterility
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.
Fallon Wellness Pharmacy is recalling Methylcobalamin/Hydroxocobalamin injections due to a lack of assurance of sterility. The affected product was distributed in New York.
Fallon Wellness Pharmacy is recalling Methylcobalamin/B-Complex Injection vials due to a lack of assurance of sterility. The affected product was distributed in New York.
Fallon Wellness Pharmacy is recalling 8 vials of Papaverine/phentolamine/prostaglandin injection in New York due to lack of assurance of sterility.
Fallon Wellness Pharmacy is recalling 43 vials of Prostaglandin Rx injections in New York due to a lack of assurance of sterility.
Fallon Wellness Pharmacy is recalling 4 vials of Papaverine/phentolamine/prostaglandin injection in New York due to lack of assurance of sterility.
Fallon Wellness Pharmacy is recalling specific lots of Papaverine/phentolamine/prostaglandin injection in New York due to a lack of assurance of sterility.
Fallon Wellness Pharmacy is recalling 6 vials of Papaverine/phentolamine/prostaglandin injection in New York due to a lack of assurance of sterility.
Fallon Wellness Pharmacy is recalling 70 vials of Hydroxocobalamin injections in New York due to a lack of assurance of sterility.
Fallon Wellness Pharmacy is recalling 8 vials of Papaverine/phentolamine/prostaglandin injection in New York due to a lack of assurance of sterility.
Fallon Wellness Pharmacy is recalling 56 vials of Methylcobolamin injections in New York due to a lack of assurance of sterility.